Job title: Quality Manager
Location: Edinburgh
Salary: circa. 50K (D.O.E)
One of prestigious multisite CRO clients that provide laboratory-based analytical testing, specialist consulting, and contribute to research and development within the life sciences sector are actively looking to recruit a quality manager for their Edinburgh biologics site. You will play a pivotal role in expanding and improving the existing QMS, with a specific focus on GMP Assay activities for the release of Biological Drug Products. You will collaborate with the wider Quality team, site Laboratory Support, and Histology Scientific staff to ensure GCP compliance within the analytical laboratory areas. Additionally, you will support R&D departments. This role presents an excellent opportunity for professional growth and career advancement.
The role:
• Collaborate with the Head of Quality to maintain and enhance the Quality Management System (QMS).
• Implement the eQMS across the company and ensure personnel are trained in relevant regulations and QMS requirements.
• Lead customer/regulatory audits and inspections of the facility.
• Design, maintain, and execute the site inspection schedule.
• Expand the current QMS to incorporate GMP Biologics analytical testing for drug products.
• Perform inspections and report critical or major deficiencies to the Head of Quality and Lead Operations personnel.
• Maintain the document control system.
• Conduct and review investigations on non-conformances or deviations, as well as OOS/OOT investigations, and support CAPA and customer complaints.
• Initiate and lead Quality Improvement activities.
The candidate: the successful quality manager will have:
• Proven experience in GMP requirements associated with release testing.
• Previous experience with regulatory inspections and customer audits.
• Track record in developing and maintaining Quality Management Systems within a pharmaceutical organization.
• Ability to drive quality and a compliant culture forward, and to investigate and draw conclusions to support CAPA and customer complaints.
• A desire to develop a long-term career within a large organization.
The package: (minimum)
• Full-time position, 37.5 hours per week.
• Some travel may be required.
• Pension scheme
• Healthcare Cash Plan
• Retail Discount scheme
• Cycle to Work scheme
• Local Reward & Recognition schemes
Keywords: Quality Manager, GMP (Good Manufacturing Practice), QMS (Quality Management System), Life Sciences, Pharmaceutical, Biotechnology, Immunology, Neuroscience, Biophysical, Histology, GCP (Good Clinical Practice), Analytical Testing, Laboratory, Compliance, Regulatory Inspections, Customer Audits, Quality Improvement, CAPA (Corrective and Preventive Action), Non-conformance, Deviations, OOS (Out of Specification), OOT (Out of Trend).