Senior QA Specialist, GCP/GLP
- Experience Level
- Experienced (non-manager)
Do you pride yourself on your integrity? We do what’s right for employees, patients and partners, and so can you.
Oxford Biomedica’s Quality Assurance team is responsible for the companies quality processes and systems, in compliance with GMP, GLP and GCP guidelines. The team are accountable for internal and external audits, quality compliance and control.
We are currently recruiting for a Senior QA GCP/GLP Specialist to join us to provide additional knowledge and capability to the QA Team.
Your responsibilities in this role would be:
- Participate in the development, implementation, and maintenance of the company’s GCP & GLP quality management system and facilitate continuous improvement.
- Provide GCP and GLP QA oversight and support to internal staff and represent QA on GCP & GLP Related project teams.
- Develop and implement annual audit strategies, and quarterly GCP & GLP audit schedules.
- Schedule, oversee and perform (either directly or via external auditors) routine and non-routine quality assurance audits to include, but not limited to: clinical investigator sites, animal testing sites, vendors, process, and system.
- Assist in the selection of external auditors, coordinate audits, and associated documentation in a timely manner.
- Support internal and external GLP testing to ensure compliance with guidelines, SOPs, protocols, and industry standards.
- Conduct QA review of GLP methods, data and reports.
- Assure/coordinate proper and complete resolution of findings/non-compliant situations in a timely manner, including approval of corrective action/preventive action (CAPA) plans, as necessary.
- Conduct QA review of GCP protocols, ICFs, CSRs and other clinical trial specific documents.
- Participate in the preparation and conduct of inspections and audits performed by regulatory authorities and other parties.
To be successful in this role, you will have the following skills and experience:
- Bachelor’s Degree in a scientific discipline
- A strong working knowledge of GCP, GLP and ICH requirements
- Previous experience within Advance Therapeutic Medicinal Products (ATMPs)
- Proven experience in the Pharmaceutical industry within QA
- Strong verbal and written communication skills
- Excellent organization and multi-tasking skills
- Ability to think strategically in order to improve current processes
- Ability to work independently and prioritise with minimal supervision
- Ability to work effectively across a matrix organisation
Do you want to feel inspired every day? We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment and team work, and so can you.
Collaborate. Contribute. Change lives
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