A pharmaceutical company is looking for a Senior QA Officer to join their growing team. You will maintain and improve Quality Systems for the site GMP and GLP activity, and maintain Quality GxP compliance with Global Quality, GMP and Regulatory Requirements. This will include management of all company quality policies, procedures, processes, programmes and practices, to assure the company of continuous conformance with appropriate international standards and regulations. You must hold a minimum of a life science degree and have previous QA experience to apply for this role.
- Advise Junior QA staff with all activities related to QMS
- Manage direct reports within the QA team if applicable
- Support all staff with all activities related to QMS
- Support all staff and laboratory personnel working on GxP studies
- Support all staff with the validation/ calibration/ maintenance of laboratory equipment and supplies
- Understand and implement procedures and practices according to industry standards and in compliance with Good Manufacturing Practices (GMP) EC Guide Volume IV (Current) as defined in ‘Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007’ published by the MHRA and Directives 2001/20/EC and 2003/94/EC, UK SI 1999 No. 3106: The Good Laboratory Practice, US FDA 21 CFR §§ 210 and 211, ISO standards (i.e. ISO 9001, 13485), Sarbanes Oxley and 21 CFR 820.
- Tracking and reporting of key quality performance indicators.
Quality Management System (QMS):
- Maintain and improve Quality systems within the QA department including but not limited to, document control, supplier qualification, technical agreements, quality records, and internal/external audit programme.
- Review and approval of change controls, deviations, OOS, CAPAs, Facilities and Equipment work records, audit comments and other related quality records, providing QA input into their generation.
- Establish and review of Quality documentation such as SOPs and Forms.
- Support the retention and archiving of records.
- Responsible for ensuring the companies instructions (written, oral, diagram or schedule) conform to the established industry best practice.
- Review and edit study plans, testing protocols, reports and related documents for scientists where appropriate.
- Support QA resourcing and workflow management.
- Responsible for managing all internal and external audit programs, including but not limited to supply chain audits, process audits. This includes establishing the compliance requirements, collecting objective evidence, and writing audit reports to ensure the quality management system is operating effectively.
- Conduct internal and/or external audits to ensure compliance to GMP and other applicable standards.
- Provide advice and answers questions about quality including: product specifications, supplier requirements, testing, inspections, part verification, equipment calibration, corrective actions, non-conformances, benchmarking and represent the client internally.
- Provide advice to junior QA staff and direct reports if applicable.
- Life Sciences degree minimum
- 5 years’ Quality Assurance experience, GMP/GLP background desirable
- Internal audit experience required
- Familiar with QMS, deviations, CAPAs, validations, batch release documentation, continuous improvement
• Some experience of CRO/CMO pharmaceutical industry
Job Ref: 5485