QA Specialist Healthcare
Jobs in Science
Reading, Berkshire
Responsible for Initiative Support for Personal Health Care Europe (Cough & Cold, Vitamin Mineral Supplements, Sleep and Nerve), supporting activities of the R&D delivery team at all stages of the innovation cycle as per our Technical Readiness Roadmap deliverables.
Responsible for championing a Quality by Design methodology and building QA mastery and expertise within Personal Health Care to ensure compliance with corporate and regulatory requirements. Trains and coaches site and system leaders on corporate, sector and regulatory requirements. Facilitates and enables partnerships with appropriate functions e.g., Engineering, SMO, Market, R&D, etc. to implement effective work processes, eliminate losses and reduce risk.
Key Responsibilities:
• Approval of the technical specifications and validation protocol/report to enable production readiness.
• Liaison with site QA to ensure that any specific documentation requirements are known and planned for.
• QA approver on Change Control linked to initiatives (Veeva GTRAQ).
• Responsible for ensuring that QATA with manufacturing sites and DC’s are in place before initiative hand-over.
• PHC category site support for investigations, deviations/CAPA’s etc.
• Provide input to the design of consumer tests to ensure that GMP requirements are maintained.
• Provide QA support for qualification of new raw and pack material suppliers for PHC Managerial responsibilities.
Qualifications:
• Degree in Health related science, life science, pharmacy or medical degree with a minimum of 5 years professional QA experience.
• Comprehensive demonstrated working knowledge of principles and concepts of Quality Assurance and Contract Manufacturing Organisations.
• Understanding of basic manufacturing processes in terms of making and packing of multiple product forms using GMP standards.
• In depth knowledge of manufacturing medicinal products and food supplements.
• Understanding of the Innovation work processes, SIMPL process, quality systems, stability, validation and GMPs
• Able operate with great autonomy in a dynamic environment with the ability to think strategically, lead and influence people