If so, there are 2 x newly created permanent opportunity available for QA Officers to become a key member of the Quality Assurance team and undertake a range of activities in the maintenance of the Quality Management System.
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.
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 2 – 3 years’ experience working within a GMP manufacturing environment within a pharmaceutical or biopharmaceutical company working with biologics etc. or 1 – 2 years’ experience in a Quality role.
- 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