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Specialist Quality Assurance - Validation West Greenwich United States,
Posted on : 01 May 2017
Quality Assurance Specialist - Validation will lead the development and execution of Validation strategies as well as ensure Validation activities are performed in a consistent and controlled manner to support the manufacturing of bulk pharmaceuticals. The role will provide Validation Quality oversight for Process, Computer, Equipment and Cleaning Validation.Responsibilities:Provide leadership and coordination of validation activitiesDevelop PPQ strategy for NPIsDevelop/Update Validation Master PlansEnsure compliance to Part 11Author validation sections for filings and /or provide data verificationDevelop Validation protocols/reportsQuality review and approve Validation Documents including: DT, CRSIQ/OQ, RTM, FT/FTF, protocols, reports, etc.Develop and mentor junior staffChampion Operational Excellence ProjectsEnsure alignment with regulatory guidelines and industry standards.Review requirements and source documentation (MBRs, PDTs, PCSRs, SOPs, Specifications), for use in development of Validation documentsProvide guidance for the generation, resolution and closure of deviations.SOP development, review and approval " Provide Change Control AssessmentsNC/CAPA initiation/ownershipGenerate/facilitate quality risk assessments for automation and equipment (QRAES)Participate in internal and external auditsInterpret and execute policies/procedures and lead validation engineers on an ongoing project basisCoordination of activities between Amgen teams (Validation, Manufacturing, F&E, Automation, QC, etc.).Basic Qualifications:Doctorate Degree ORMaster's Degree and 3 years of Quality experience ORBachelor's Degree and 5 years of Quality experience ORAssociate's degree and 10 years of Quality experience ORHigh school diploma/GED and 12 years of Quality experiencePreferred Qualifications:6 + years of experience in pharmaceutical or biopharmaceutical environment with cGMP FDA regulated operations/engineering/manufacturing/quality environmentTechnical understanding of pharmaceutical/biotechnology unit operationsDirect Validation experience with pharmaceutical or biopharmaceutical processes including the development of strategies, master plans, protocols and reports.Proven experience in multiple regulatory inspectionsKnowledgeable in current industry standards and regulatory trends as they pertain to Validation of pharmaceutical or biopharmaceutical processesCommunication, presentation, organization, team development and leadership skillsKnowledge of risk-based validation methodologies, such as GAMP5, regulatory agency expectations, biopharmaceutical processes, project management, strategic resource management and business analysisAbility to evaluate compliance issues and interact with regulatory inspectorsSystem knowledge and experience with EBR, Delta V, NC, CAPA and Change Control processesAbility to manage multiple complex tasks at one timeAmgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
US, Rhode Island, West Greenwich
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