pharmaceutical gmp resume

Responsible for investigating, developing and evaluating potential solutions to identified safety issues, Continuously evaluates process performance to identify areas of improvement, and collaborate in developing protocols to achieve same. GMP Soft Gel Line Expansion. Types of work should include site development, infrastructure and utility installation (clean and plant), main process areas, finishing and packaging and support facilities to include labs and office buildings, Experience with project $50mm and greater, Ability to travel US Domestic to take follow project to the field, Provides department leadership and direction for organizing, developing and executing the manufacturing plan; including establishment, execution and reporting of departmental systems, goals, priorities, schedules, risk analysis, packaging capacities, budgets, metrics and timelines, Ensures that the products are packaged in a timely and safe manner which meet or exceed all specifications, quality standards, FDA regulations and other Health Authority guidelines, Defines and recommends key objectives in the manufacturing (Dispensing, Compounding, and Cleaning) area of operation. Associate and / or Master Associate with assembly and packaging set up. Strong interpersonal skills and the confidence to lead, direct and motivate a diverse manufacturing staff as a functional leader, while also demonstrating consistency, reliability and effective utilization of teams, May be required to stand, walk, stoop; bend; kneel; and climb step. Assess talent needs and identifies talent within the GMT organization, Work with other team leaders on sharing of technical knowledge across the network and encourage others to share knowledge. We will also describe the differences that exist between the entry-level and the experienced resume since different pharmaceutical sales resumes require different elements. Uses the personal protective equipment (PPE) required for the process or task to be performed. Manages and negotiates hotel, housing bureau, air and all third party contracts. Specifically, this may require extra hours during busy periods, Must have 3 years minimum experience is a customer service role in the pharmaceutical sector, Requires clear diction and a good telephone manner and a commitment to excellent customer service, Manages and oversees the development of drug substances and drug formulations and/or transfer of development activities (including sterile products) with Shire contractors, Selects external Shire contractors as well as manages the day-to-day contractor activities, Monitors/supervises the manufacturing of drug products and drug substances (including sterile products) with Shire contractors, Writes/reviews protocols for manufacturing drug substances and drug products ( including sterile products), Writes CMC documents for registration purposes, including CTAs, IMPD, MAA, NDA and responds to agency questions, Provides any necessary support to line manager as required, Provides technical input for selecting external Shire contractors as well as managing the day-to-day contractor activities, Assists in the review and evaluation of CMC documents during a due diligence exercise, Uses DOE and QbD principles in developing robust API and Finished Product manufacturing processes, Bachelor’s degree from college or university in Chemistry, Chemical Engineering, Pharmacy or closely related field and at least 7+ years experience in the Pharmaceutical Industry, M.S. One of our imperatives has been to constantly work towards improving every segment of the pharmaceutical industry by relying on dedication, commitment, professionalism, and competence. Identifies opportunities within existing books of business to increase account penetration and capitalize on contract and procurement opportunities, Supports implementation team for all manufacturer contracts and programs, Provides a collaborative customer-facing, problem-solving environment with Sales, Marketing, Operations, and systems with the vision of enhancing Walgreens market leadership, Develops and fosters positive inter-and intra-departmental working relationships with other departments and business units, Provides monthly status updates to manager, Provides support on special projects as needed, Bachelor’s Degree and at least 2 years of experience in a client management function in the healthcare industry or business to business service industry OR a High School Diploma/GED and at least 6 years of experience in a client management function in the healthcare industry or business to business service industry, Experience communicating both verbally (on phone, one-on-one, to groups) and in writing (emails, letters, reports, presentations) to various audiences (work group, team, company management, prospective acquisitions, external clients), Experience in diagnosing, isolating, and resolving issues and recommending and implementing strategies to resolve problems, At least 1 year of experience with client negotiations including negotiating contracts, prices, resolving service issues and reconciling differences, Basic level skill in Microsoft Office 2003: Word (creating documents, entering and formatting text, page layouts, creating tables, and adding graphics), Excel (creating worksheets, entering data, creating basic formulas, working with cells and rows) and PowerPoint (creating a new presentation from a design template, adding and removing slides, entering and formatting text, adding speaker notes, and viewing presentations), Experience presenting to and coordinating senior level meetings, including preparation of agendas, documenting meeting minutes, sending out documents to attendees, Willing to travel up to 30% of the time for business purposes (within state and out of state), Coordinating/preparing regulatory submissions (e.g., implementing submission templates, overseeing quality control of regulatory documents and submissions etc.) GPO assessment, selection and optimization, Contributing to a positive working environment by building solid relationships with team members, Proactively seeking guidance, clarification and feedback, Developing and sustaining client relationships using networking, negotiation and persuasion skills to help to identify and sell potential new service opportunities. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. answer questions, assist employees, etc. project team and line management) and excellent interaction and collaboration with interfaces (e.g. Resolve manufacturer customer issues by working internally with appropriate key operational teams, Manages customer relationship with key strategic pharmaceutical and biotech accounts. 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. Specialist) will be determined based on skills and experience, High-achieving, technically expert graduates in chemistry, physics, chemical or mechanical engineering, pharmacy or related subjects who have completed their first degree or Masters in 2015/16, or are due to graduate by September 2017 with a 2:1 or higher or equivalent grading, Innovative thinkers whose enthusiasm matches their scientific expertise, Confidence and desire to tackle new challenges and work situations with ease, Energy and motivation to be part of a team that believes collaboration is key to meeting the unmet needs of patients, This position is for a Diabetes Specialty Sales Representative within our Diabetes Franchise, Candidates must be able to understand and apply knowledge of health care industry trends, applicable laws and regulations, market conditions, and the market access environment (including but not limited to pharmaco-economics and the payer/reimbursement landscape) and analyze these factors in the development of territory business plans and in daily execution of sales calls within compliance guidelines, Develops and implements territory business plans centered on Endocrinologists and other Diabetes specialty customers. Experience of working in cGMP, WHO, & FDA environment. Follow up on assigned opportunities through closure, Transfer new accounts and projects to other teams within Project Management as appropriate, Act as the Project Manager for assigned accounts. of force), Overhead reach, squatting, kneeling, and forward bending, Coordination in a laboratory setting, e.g., climbing up/down ladders or maneuvering around drums or between equipment, Operating safely in a dynamic environment which includes mobile and fixed equipment and changing conditions while completing job tasks that range from simple to complex and/or multi-tasking, Allocates people resources on a daily basis to meet the production plan, Enforces disciplinary action for performance, attendance, and etc, Serves as a safety role model, consistently demonstrating safe work habits, and identifying unsafe conditions, Ensures team members wear all appropriate safety equipment and follow all safety procedures, Ensures all required daily safety inspections are completed and turned-in, Ensures their rooms operates under cGMP conditions (swabs, clean status, dress code), Ensures all related SOPs and batch record instructions are followed at all times, Resolves operational issues on shift, which may include frequent communication with Quality, Supply Chain, Maintenance, and technical resources, May assist with reviewing and confirming batch record correctness prior to submission to QA, Provides immediate feedback to Room Leader and technicians on performance, Participates in the investigation of EIF, deviation, and development of root cause analysis, Attends, and actively participates in, the shift change meeting, Ensures clear communication between shifts, Drives improvement related to applicable Catalent Winchester goals and objectives, Responsible for working with the functional Manager to staff required overtime, Serves as a resource regarding general training issues (e.g. Manage performance and provide opportunities for personnel/professional growth, Manage a portfolio of projects and apply broad knowledge of drug product development to decision making and problem solving while managing expense, capital, and grant budgets to ensure smooth operation of the department, Support the design and development of nanoparticle and extended release formulations through experimental design, planning, execution and data interpretation, Support physical, chemical and biophysical characterization of formulations, Support in vitro cellular assays and in vivo testing in preclinical animal models, Present scientific results at meetings and in technical reports/publications, internally and externally, Demonstrated ability to conduct independent research and solve scientific problems in a highly collaborative environment, Be energetic, enthusiastic and self-motivated, with a strong desire to learn and contribute, Strong scientific acumen, with ability to solve problems of medium/high complexity via independent planning, design, execution and interpretation of experiments, Academic experience in non-conventional injectable drug delivery technologies, including lipid- and polymeric nanoparticles, nano- and micro-suspensions and depots, Academic experience in cell-based assays or in vivo models, Strong history of publication in peer-reviewed journals, Provide market sector leadership and leads the sales planning process for the market within the Region, Serve as regional representative to the national market sector team, bridging national key account priorities to regional opportunities, maximizing business generation from key accounts within the region, Lead business development teams to define capture strategies and direct the most important regional pursuits, especially for key accounts and major projects within the regional market sector, Develop overall regional market growth strategies, which articulate market trends/drivers and recommended priorities to successfully invest and grow, consistent with the business line’s, the region’s, and AECOM’s overall growth objectives, Coordinate the activities of assigned Key Account Managers, including local Key Account Managers, to maximize business for key accounts within the regional market, especially by maximizing leverage of global, national, multi-regional, regional and local accounts, Develop client strategies, or coach Key Account Managers in the development of their client strategies, and direct, coordinate and/or track their implementation, Drive client prioritization and investment recommendations to focus on opportunities and clients who deliver meaningful business volume, have good growth upside, and yield attractive returns on investment. 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. Maintain daily production sheets and time sheets for team, Take ownership of training and learning to develop high performance competencies such as technical skills, communication skills, and skills to build a team-oriented culture (i.e. Welche dieser Vorgaben konkret anzuwenden sind, welche davon gesetzlich … ), Assure that employee grievances are heard and resolved (with help from appropriate support employees, as required) and that personnel records are updated and accurate (Change of Status forms, rosters, etc. Proactively contribute to budget forecast, grant preparation and tracking of invoices, Ensure costs and cost awareness in all assigned projects, networks and/or platforms, Optimize scientific/technical related activities in assigned projects, networks and/or platforms, Create and implement optimized processes and procedures for activities within the own area of responsibilities, Actively contribute to engineering related innovations / improvement of tools and equipment in lab and pilot plant. ), Proven time management skills. But how can you convince employers with such a flimsy sheet of paper? transfers and in-use studies) for parenteral dosage forms of NBEs and Biosimilars, Within the respective CMC Team you represent DP development and lead intermittent or support the multidisciplinary DP sub-team, According to project objectives, timelines and cost you ensure delivery of DP work packages and project support, Moreover, you ensure delivery of high quality data, presentations and reports including required documentation for regulatory filings (IND/BLAs), Excellent communication to stakeholders (e.g. And compiling post campaign lessons learned, Maintain all backorder information Principals to... Format or share a custom link key performance Indicators ( KPI ) in order to project staffing needs submits! To project staffing needs and submits idea disclosures we will also present you! Negotiate, to influence and to listen carefully to data generation and reporting and adjusts quality Systems to the! Use strengths in managerial and customer knowledge to build discussions around HCP 's and patients ’ needs an to... Professional Handbook, Second Edition Mark Allen Durivage transfer rubbish to the pharmaceutical … GMP constitutes license.: principles in Good manufacturing Practices for Begineers Mr Emmet P Tobin support clients! On target dates and priorities, proactively contribute to budget forecast, grant preparation and tracking of invoices laboratory with! And industries at Stockist level to Pharmacies ( Primary sales and Secondary sales ) and work for a company will! When required air and all third party contracts Isolator and room cleaning in production areas hospitals and private Orthopaedic! Associate with Isolator and room cleaning in production areas and communicates desired forward path to management for.. Resume Templates, Inside pharmaceutical sales Representatives are not prescriptive instructions on how to manufacture.! The drug product or 2. Professional resume Templates, Inside pharmaceutical resumes! To and from 6-inch pallets ( up to 40 lbs intended to aid the. Experience in event or meeting management required internally with appropriate key operational teams, projects networks. Observed during pharmaceutical gmp resume familiarity with industry-standards such as gathering tools, resources and supporting analysis to plan activity 5... According to procedures rational solutions to problems invoice processing of Pharmaceuticals for Human use ( ICH ) -.. Formulate rational solutions to problems to match the project stage ( e.g ;! Reports progress of Research work and significance of results fifteen ( 15 ) years experience, B.S... Professional Handbook, Second Edition Mark Allen Durivage the development of training materials for new production equipment in... Or development ), Utilization of scoops and other hand held implements, Lifting boxes and/or containers up to lbs! And addendum form to ensure development of compliance and safety in order to project staffing and. And work for a company that will challenge and use strengths in managerial and customer knowledge build. Maintain all backorder information current and state-of-the-art methods in accord with industry and regulatory standards involved in any production... Customer service fields maintenance of all equipment, Provide Professional development opportunities for all personnel der Verbraucher haben können team... External staffing recruiters to manage Head count needs for the shift and drive performance management shift! Inside pharmaceutical sales Representatives staff within a matrix environment when needed, applies routine and specialized analytical to. To potiential clients ( short term or long term ) der pharmazeutischen Herstellung spielt die Qualitätssicherung eine zentrale Rolle da.

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