Familiarity with industry-standards such as ICH, IMPD, XEVMPD. Pharmacist @ CVS Health. Completed work is reviewed, from a long-term perspective for results, Responsible for training, developing, and advising staff. Meet the production schedules outlined by team and/or Supervision, Ensure product quality by performing in-process checks, complying with cGMPs, being alert for unacceptable quality of incoming and outgoing materials, initiating quality improvements, and participating on quality improvement projects; Communicate quality and other non-compliance issues to supervision in a timely manner, Review and approve work output for team members by using validated methods, Perform work, on personal computer (i.e., Business Operating Systems, read and respond to electronic mail in a timely manner, Microsoft Software, etc); Complete, maintain, and update production documentation (both electronic and paper) to perform material movements, material take-outs and yield determinations by following SOPs and utilizing systems as required such as Systems/Applications/Products (SAP), Manufacturing Execution Systems (MES), Electronic Batch Records (EBRs), etc, Operate motorized and non-motorized material handling equipment for assigned stocking operations as well as stand up and sit down forktrucks as needed, Inform department Administrative Assistant when to order supplies as needed, Coordinate the utilization of outside contractors and vendors as needed, Ensure safe work environment by following all safety procedures, workplace standards and company guidelines, and ergonomic rules, including proper use of personal protective equipment (PPE), standard operating procedures (SOPs) applying to a particular process or area, Current Good Manufacturing Practices (cGMPs), Occupational Safety and Health Administration requirements (OSHA), Lockout Tagout, Dispense components, operate, clean, set-up, changeover and maintain equipment and rooms to manufacture products. Resolves issues with account and prepares validation system (ECP) to receive detail claim data, Reviews suspect claim records and determines if record should be disputed for payment. Writes complex explicit documentation for new procedures, as well as for current procedures, Supports the qualification and startup of new equipment in the Fill and Finish area, Develops training manuals and / or on-the-job training materials for new and existing equipment and processes in assigned department. Outlines strategy, communication plan, and process for assigned conventions/congresses. Procurement responsibilities include providing information, guidelines and collaboration to facilitate the procurement process. All work is documented in controlled documents (batch records, logbooks or SOP attachments) in accordance with SOP. In some circumstances, may be requested to act as the PST-L (Product Strategy Team Lead) for R&D functions, May be a key member of joint Development Committees with partner development organizations, Leads and assists in the development and implementation of departmental processes, procedures and policies, Is an active member of the Pharmaceutical Sciences Leadership Team, May deputize for the VP, Product Development in various R&D staff meetings and tasks, Bachelor’s degree from an accredited college or university in Chemistry, Chemical Engineering, Pharmacy, or closely related field, Generally has at least 12 years’ experience (or 10 years plus PhD) in the Pharmaceutical Industry, Must have a least 10 years’ experience in formulation development and/or manufacturing, Must be able to perform legal research and write persuasively, Deposition and trial experience is a plus, 2-3 years of advertising agency experience, Ability to perform basic tasks in Adobe Creative Suite, Excellent presentation / public speaking skills, Digital (website) and print (long forms) experience, A creative portfolio of work showing own brand concepts and campaigns, 5+ years of relevant professional experience, TV production experience, including directing voice-over talent, An impressive portfolio of work showing at least six examples of own brand concepts and campaigns, Experience developing big digital and social conceptual ideas, Lead day-to-day management of projects, as well as overall account management, including, Run internal and external meetings, ensuring agreements are met, Ensure projects meet client, agency and regulatory requirements, Forge strong client relationships with Creative, Production, Planning, other agency departments and partner companies, Evaluate the input and ideas of Creative, Planning and Media relative to strategy and client preference, Act as key category expert about client business and brand performance, Act as contact for client research plans and implementation, Compile billing and income forecasts and reports, 5+ years pharmaceutical advertising experience, including both HCP and DTC—a solid knowledge of the business is required, Strong ability to lead, applying clients’ strategic priorities and business objectives to daily activities and tactics by way of exceptionally effective communication, Coordinate and manage multiple projects from conception through completion, Communicate scheduled deadlines and provide effective warning when delivery dates may be in jeopardy, Coordinate team briefings, internal reviews of creative, and all other meetings needed to complete any given project, 3+ years agency project management/traffic experience; some pharmaceutical advertising experience required for this position, True problem solver—able to anticipate roadblocks and offer solutions, Highly detail-oriented while managing multiple tasks and tight deadlines with confidence, Exceptional interpersonal skills necessary to interact with a range of personalities and establish effective relationships at all levels of the organization, Help establish and maintain team operating principals, formalizing the team’s strategy, structure, processes, templates, and operating norms to implement department vision, Ensure proper scope allocation and adherence in conjunction with the Director of Operations, Senior Account Management, and Finance, Identify and suggest process improvements to enable efficiency, Interview prospective Project Management candidates, Train new and mentor existing Project Managers, providing guidance and coaching to assist in individual growth and development, Own a brand or brands as necessary based on scopes and staffing—either individually, or in a supervisory capacity with junior members of Project Management team, 5+ years agency project management/traffic experience; 2+ years in a supervisory capacity—pharmaceutical advertising experience required, Keen understanding of advertising principles and creative project process terminology, Exceptional interpersonal skills necessary to interact with a range of personalities and establish effective relationships at all levels of the team and organization, Serve as liaison between Account Management, Creative, Studio, and other inter-agency partners, Communicate project requirements and procure supporting materials to ensure that projects move through the agency in a timely manner, Monitor and follow-up with all appropriate departments on project development, Initiate, develop, drive, and revise schedules, Delivering significant business results that utilizes strategic and creative thinking, problem solving, individual initiative and the following abilities, Leading project work streams, emphasizing the ability to build solid and collaborative relationships with team members and also work autonomously with little direction, Communicating effectively in written and verbal formats to various situations and audiences, Managing and conducting quantitative and qualitative benchmarking and primary and secondary analyses of large and complex data, University Degree in Business, Finance, or Accounting, Minimum of three years of related accounting experience required, Language skills are preferable though not essential, Strong technical accounting skills i.e. Combination type RX/medical devices, drug releasing implants and topical drug delivery patches, Mathematical and statistical computation methods andtechniques, Administration, supervision and training practices and methods, Recruiting, interviewing and selecting applicants in accordance with established employment practices and methods, Current Company policies, practices and procedures, including safety rules and regulations, Responding to complex inquiries frommanagement, employees and regulatory agencies, Communicating clearly and concisely, both orally and in writing, Managing multiple projects, duties and assignments, Establishingand maintaining cooperative working relationships with others, Creation and maintenance of the Pharma/Dialyzer annual audit schedule and corresponding audit plans based on input provided from management, Create and implement a monitoring program that identifies KPIs for key QSR activities and reports these metrics to management, Ensure adherence to Corporate QS Compliance SOPs and Policies and assuring they are accurate, up-to-date and reflect current practice and reports on ineffective procedures, policy exceptions, reporting discrepancies and evaluates corrective actions and regulatory commitments, Represent the Corporate QS and Clinical Compliance group at meetings, Leads the collection, organization and dissemination of quality knowledge and training about the company, its products, and skills that enable associates to perform their jobs in a continuous state of compliance with applicable regulatory requirements, Tracking of metrics related to audit execution, tracking and closure, Perform audits according to audit schedule and coordinate scheduling of QS and Clinical Compliance activities, Based on results internal process audits, collaborate with Technical Operations, Quality Systems, and GMP Quality functions to identify CAPAs and manage and approve their completion, Contribute to the Quality Management Review, Assist/participate in inspections of FMCNA by Regulatory Authorities, Provide inspection readiness activities throughout the organization including training colleagues across Pharmaceutical organizations on regulatory interactions, Develop internal auditor training program, Interface with internal colleagues, industry leaders and regulatory experts to align audit requirements for FMNCA and provide clarity to the organization of the going-forward support model, as required, Evaluates resource allocations, manages resource and capacity analyses, and oversees the training requirements for direct reports, Participates in continuous improvement efforts to streamline compliance and simplify procedural and other requirements to ensure ease of following system requirements, Provides leadership and coaching to all direct reports and partners with human resources on employee matters, Manage the tactical execution of short- and long-term objectives through the coordination of activities with a direct responsibility for results, including costs, methods, and staffing, Technically proficient in the specific department and knowledge of industry practice and business principles. Assists with drafting of revisions to and creation of new SOP’s. Sterile product experience is highly desirable, Must be able to apply product development expertise to CMC sections of the regulatory filings, Project Management experience in a product development environment, Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines, Ability to present complex issues well in oral and written form, Ability to work independently, take initiative and complete tasks to deadlines, Excellent interpersonal, communication, analytical, and organizational skills, Ability to effectively present information to management, external contractors and employees at all levels of the organisation, Basic knowledge of project leadership tools including MS Project, In support of product development, apply broad and deep analytical knowledge and experience to the material characterization and testing of APIs and drug products, Apply knowledge and direct experience with the analytical support of synthetic peptides, oligonucleotides, and sterile products to ensure the appropriate analytical methodologies are in place and fit-for-purpose to properly support the development projects, Provide technical guidance for troubleshooting / investigating complex issues regarding analytical, stability, and process / product development, Leverage fundamental understanding of formulations, product development, and material characterization to implement analytical methodologies as appropriate for various formulations and dosage forms, Apply statistical analysis for interpretation of analytical and stability data, Author and/or review analytical methods and associated development, qualification, validation and transfer protocols and reports, Author and/or review release, in-process and stability specifications for APIs and drug products, Manage and oversee stability and analytical studies for projects. PowerPoint & Outlook), Proven ability to manage and coordinate multiple projects in a fast-paced, highly professional environment, Ability to work well with others & independently, Proven time management skills and a strong attention to detail, Must be highly organized and able to work effectively and efficiently in a demanding environment with frequently changing priorities, Extended hours and shift work may be required from time to time, Ensures full compliance with the company’s Health & Safety, Code of Integrity, and Professional Conduct policies, Appropriate attitude, constant vigilance, attention to detail and following Training SOP for training and training records, Create Demand through networking with the key stakeholders at indirect customer and specifier level of the Medical Device Manufacturing (MDM) Industry and the Pharmaceutical Industry (Packaging Eng., Regulatory Experts, Quality Managers, Operation Managers, Marketing and to less degree Purchasing and Sales) as well as Contract Manufacturers dedicated to those industries, Support and expand our relationships at Key MDMs, Communicate the value propositions through F2F engagements, lectures, training workshops and digital channels in cooperation with Marketing, Provide to MDM technical and regulatory input and arrange meetings or calls with the internal experts of the team, Promote actively new product launches and identify first usersGather market intelligence information and listen to the voice of the customer. There is an inherent risk associated with all travel, often as a result of extraordinary circumstances. Ability to identify gaps in PS technology/trends and influence change/improvements to affected areas/processes, Communication– ability to expresses one’s self clearly and concisely to key stakeholders and functional management; documents issues and/or concerns concisely and comprehensively; adjusts style, language and/or terminology appropriate for the audience. Assist the call center management with customer issues and communications when drugs are out of stock, Up to 2 years of relevant work experience, Demonstrated ability to meet multiple deadlines and manage heavy workload, ABOUT THE DEPARTMENT Procurement is responsible for purchasing all goods and services through approved channels. Many people are not aware of useful resume formats that are relevant to use in the present scenario. Fundamental understanding in DMPK, Pharmacology and Toxicology, Extensive knowledge of current Good Manufacturing Practices (cGMP), ICH Guidelines, other pertinent national regulations, compendial requirements and communicating with regulatory agencies, Must have experience in global regulatory submission requirements and processes, Leadership- develops and uses knowledge and interpersonal skills to influence and guide internal and external stakeholders towards the accomplishment of program and cross-divisional goals and objectives; adapts well to varied team dynamics and manages others team members in a respectful manner, Risk Management – ability to identify/mitigate technical, budgetary, and schedule risks to multiple programs and propose appropriate risk response strategies. with fifteen (15) years experience, or B.S. 5 years of experience Preferred, Strong knowledge and practical experience of production, inventory and planning systems currently deployed in Zoetis including but not confined to SAP, Strong knowledge and practical experience in utilizing analytical tools, spreadsheets and databases to develop reports for strategic planning and communication, Proven ability to lead, synchronize and motivate colleagues to meet short and long term objectives, Ability to conceptualize, analyze and implement new methodologies in support of improving customer service, inventory management, and business alignment, Demonstrated ability to function and influence in a team matrix environment and have excellent interpersonal and communication skills, Demonstrated understanding of Right First Time and Lean Manufacturing concepts and principles preferred, Proactively demonstrate and promote client's products to targeted and non- targeted physicians and healthcare professionals in territory and develop an appropriate territory business plan to influence their prescribing decisions for the appropriate patient, Develop programs to enhance customer engagement and assist in business plans and goals. Thanks to cookies, we can provide you with personalized content and ads, bring you social media features, and analyze traffic. All the best! of force), Utilization of scoops and other hand held implements, Lifting boxes and/or containers up to 40 lbs. Relevant experience will be considered in lieu of a formal degree, Completion of OSHA 30 hour training program is desirable, The successful CM candidate must have recent and broad experience in the design and construction of biopharmaceutical, food and heavy process industry facilities. Pharma Jobs; Clinical Jobs; Fresher jobs; Walk-in interviews; ... CV File Names and Formats. Careers in the Pharmaceutical industry are well paid. Make a list of every relevant information on a rough paper because it is easier to organize. Pharmaceutical Manufacturing Operator 02/2015 to Current Noramco Wilmington, DE As a manufacturing Operator I am responsible for the batch-wise manufacture of active pharmaceutical ingredients. To write a great resume, you are supposed to market yourself in the most efficient way. Ensure quality of international registration documents, Interact with authorities where appropriate. Therefore, during an emergency, it is your duty to provide the necessary guidance and leadership, and to promote the safety of the client, travel participants and other Maritz employees by implementing or supporting prescribed crisis procedures. Here are Resume Formats for Freshers – Best of 2021. ... Tax Senior Pharmaceutical Company Resume Examples & Samples. Drive creation of processes for technology landscaping and partner selection, Serve on joint Development and Steering Committees for partnered projects, Visual inspection of vialled products for pharmaceutical use; work is carried out under GMP, Carrying out visual inspection of filled vials, both freeze dried and liquid filled, using approved procedures, Remove defective products based on agreed reject categories, Reporting of each inspection in batch manufacturing records in accordance with GMP, Sampling raw materials and finished product, Control of finished product storage and storage areas, Document storage locations per batch in inventory, Ensure storage areas are monitored and perform checks as directed by supervisor, Communication with clients regarding labelling, dispatch, stock control etc, Generation of product labels as per client instructions, Labelling of product vials per agreed batch manufacturing instructions, Arranging dispatch of materials to Client/Clinic sites as appropriate, Book transportation to coincide with the size of dispatch to meet the clients delivery deadlines, Participation in training sessions in support of the above activities, Ensuring training record folders are suitably maintained with appropriate documentation to show competency for each activity performed, Participate in maintaining housekeeping standards and audit readiness of facility, Completion of batch manufacturing records, worksheets, forms and logbooks to the required standard in support of the above activities, Preparation of relevant documentation to support department activities, Communicate and help resolve any customer complaints as necessary, Participation in customer and regulatory audits/inspections as required, All other reasonable activities in support of department functions under the direction of the Logistics Supervisor or Production Managers, 3+ years pharmaceutical experience outside of retail industry, Strong ability to multitask and work in a fast paced environment, Flexible and adaptable, able to adjust to emerging product requirements, Excellent critical thinking and organizational skills, Must be able to evaluate literature and summarize findings, Must be a self-motivator and work independently and as part of a team, Ability to use knowledge as pharmacist to organize and develop drug information based on clinical needs of physician readers, Ability to prepare additional material or rewrite content, as needed and match publication style and requirements, Ability to create new drug monographs (tables) when new molecular entities approved by the FDA and enter them in database, Ability to update database with new indications, new dosage regimens, and other pertinent information (eg, precautions, warnings), Ability to verify accuracy of content in existing monographs, Ability to identify, correct, and review drug interactions, Detailed oriented, precise, and rigorous regarding the implementation of style guides, Working knowledge of Microsoft Office Suite particularly with Excel and Word, Develop clear event and strategic communications plans, Evaluate the value of effective corporate communications, both internally and externally, Learn how to navigate a complex organization and manage internal stakeholders, Currently enrolled in a 4-year bachelor undergraduate (minimum) program and pursuing a degree in Communications or related field, Excellent written and verbal communication skills; detail-oriented, Self-starter who can work on multiple priorities in a fast paced environment, Ability to work both collaboratively and independently, Ability to interact professionally with internal stakeholders at various organizational levels, Basic problem solving skills and project management abilities; resourceful, Strong computer skills with Microsoft Office proficiency (Word, Excel and PowerPoint), Manage/perform site projects focused on Process Validation, process optimization, process trouble shooting and new product introduction, Evaluate project budgets, forecast, expenditures and accomplishment of objectives and ensure all projects are executed on time and within budget, Open and close change controls for each project as necessary, Assess the effectiveness of current projects and identify possibilities for new projects and opportunities, Coordinates resources from Engineering, Quality Assurance, and production personnel assigned to specific projects, Furnish direction to engineers and technicians regarding project requirements, Develops and communicates project timelines and status, Generation and execution of protocols for both new and marketed products including the qualification of new chemical raw materials and components, Work with other departments to ensure identified work items are addressed in a timely and satisfactory manner, Perform filing, computer input/output tasks and prepare identified reports as required, Address internal and external customer queries under the guidance of the department supervisor/manager, Assure our business practices enhance the welfare of our customers, employees and community in which we operate, Ensure that all activities are fully compliant with all criteria established by governmental agencies, Ministries of Health and legislative requirements, Assist Allergan in achieving environmental, health, and safety goals by working safely and observing all general plant and department safety policies, Perform all assigned duties according to departmental SOP’s and cGMP’s, and company policies, Remain current on proper procedures by reviewing current, revised, and new SOP’s relating to the job and to the department, Complete and remain current with all required cGMP and safety training, Strong financial and cost accounting skills desired, Knowledge and understanding of current Good Manufacturing Practices (cGMP), Knowledge and understanding of Regulatory Compliance criteria established by Governmental Agencies, Boards of Health and Legislative Requirements, such as FDA, OSHA, EPA, and DEA, Basic knowledge of strategic and tactical issues in an operations environment, Ability to handle multiple projects, duties, and assignments, Ability to read, comprehend, write, and communicate effectively in English, Ability to carry out detailed written or oral instructions, Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment, Knowledge and understanding of personal computer operations, including Windows-based computer systems such as Microsoft Office applications (Word, Access, Excel, PowerPoint, MS Project), with an ability to learn other computer based systems, Understanding of equipment qualification / calibration concepts, Understanding of pharmaceutical raw material tests and raw material characterization, Ability to perform intermediate statistical computations (Cp, Cpk, regression, analysis), and practical application of statistical software, Knowledge and application of process improvement for all types of products, Knowledge of process / cleaning validation processes, Ability to employ sound leadership skills for providing guidance to project teams, Ability to solve practical problems, considering a variety of concrete variables in situations where only limited standardization exists, Responsible for the development and pre-validation of analytical methods using multiple analytical techniques including HPLC, CBPA, qPCR, Western blots, UV and other general methods as needed. 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