Biopharm Quality Assurance Advisor
QA oversight supporting the internal GMP clinical manufacture and analytical testing of monoclonal antibodies produced via mammalian or microbial host cells in the GSK R&D Biopharmaceutical Pilot Plant. QA oversight of Biopharmaceutical cell banking activities.
• Ability to demonstrate GSK's corporate Values, Expectations and Code of Conduct.
• Promote a high level of GMP awareness and compliance in business partner areas (primarily, Biopharm Product Development & Supply) and project teams.
• Approve GMP documentation, including Standard Operating Procedures, Master Batch Records, validation life-cycle documentation (IQ, OQ, PQ, VRRs), change controls, and other controlled documents from business partner areas.
• Quality lead in investigations, such as Quality Investigations and vendor complaints and make recommendations for corrective and preventative actions, and to follow up on the implementation of those recommendations.
• Write Standard Operating Procedures pertaining to Quality Assurance and business partner GMP systems.
• Participate in internal assessments to measure compliance with appropriate GSK policies and procedures.
• Provide input and participate in the preparation for GSK corporate and regulatory inspections.
• Participate in the implementation of the Quality Management System including, provide subject matter expertise and performing relevant impact assessments, consideration of quality policies as part of control document approval.
• May develop and deliver GxP training to business partners.
• Conduct review of completed manufacturing batch records.
• Perform product technical release activities, including review/approval of executed batch record and Certificate of Analysis approval.
• Generate and approve relevant technical release documentation.
• Act with integrity and confidence.
• Contribute to delivery of group objectives.
• Participate in Product Quality Pharma R&D local and international process improvement initiatives.
• Assure products meet regulatory requirements and that they conform to regulatory submissions.
• May participate in audits/assessments as well as multiple projects of high priority including regulatory inspections and high risk non-compliance issues.
• May represent or lead a project, program or team activities.
• Identify business or reputational risks associated with job responsibilities and communicate these upward.
• Participate in, contribute to or may lead the training, education, guidance and influencing of customers/business areas on quality and compliance policy and practices.
• Provide advice to the business groups on day to day issues.
• May identify and mitigate compliance risks to GSK through effective assessments and/or via providing advice and consultancy to Product Quality Pharma R&D and business units regionally and globally
• Liaise with customers to provide compliance advice/input.
• Identify, communicate and may monitor business changes that could impact on quality or compliance within the department and across departments.
• Establish improvement processes, as needed, linked to GSK business needs.
• Communicate and interact at various levels in GSK.
• Comfortable with ambiguity and demonstrated ability to use Risk based decision making.
• Bachelor of Science Degree
• At least 3-5 years relevant experience in a cGMP Manufacturing or Analytical Testing facility.
• Experience with Core Quality Systems in a GMP environment (for example, Deviation Handling, CAPA Management, Change Management, Documentation authoring/approval, or Validation Lifecycle Documentation).
• Knowledge of manufacture and/or testing of Biopharmaceutical Bulk Drug Substance (BDS).
• Ability to communicate, influence and negotiate at various levels.
• Demonstrated ability to apply Risk Based Decision making.
• Direct experience with quality oversight activities in a manufacturing facility.
• Direct experience with manufacture or testing of Biopharmaceutical Bulk Drug Substance or Cell Banking.
• Broad knowledge of the R&D Drug Development Process.
• Experience with validation lifecycle requirements as related to a GMP Manufacturing
GlaxoSmithKline is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery of strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer.
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