The company is creating cutting – edge therapies to help change people’s lives in their state-of-the-art GMP manufacturing facility in Edinburgh.
The Role:
You will be responsible for using your GMP background and knowledge to carry out activities to maintain the QMS as well as lead QA Officers in day to day activities and act as a trainer in specific SOP’s where required.
Key Responsibilities:
- Reviewing, writing and updating SOPs, batch records and production material specifications to ensure compliance with company policies, practices and relevant standards and guidelines.
- Writing, implementing, reviewing and maintaining SOPs, policies and other documentation for QA activities.
- Administration, review and approval of key QMS documents including incident reports, change controls, CAPAs and risk assessments.
- Performing data review audits including batch records, validation documents, development documents and QC data.
- Performing and reviewing internal and external audits to determine compliance with GMP and identification of areas for improvement.
- Issuing, reviewing and closing Corrective and Preventative Actions (CAPAs).
- Reviewing and approving suppliers/service providers including supporting with audits of critical suppliers where required.
- Supporting the Quality Assurance Supervisors and Managers with hosting customer audits and regulatory inspections.
- Compiling quality metrics to facilitate monitoring of the company’s quality systems
Experience:
- You will have a Life Science degree and 3 or more years’ experience working within a Quality Assurance role in GMP manufacturing environment within a pharmaceutical or biopharmaceutical company working with biologics etc.
- You must have experience in mentoring, leading or supervising QA Officers and trained them accordingly
- You would ideally have experience working with quality management systems and compliant with FDA, UK, EU regulations
- You would need to have some experience in report writing and customer visits or audits
- You need to have strong attention to detail and excellent communication skills