Your Responsibilities:Job Description:
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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