Quality Officer - Compliance and Process Support

Quality Officer - Compliance and Process Support

An opportunity has arisen with our client to join their Quality Assurance team, reporting to the Principal Quality Officer – Compliance and Process Support. The purpose of this role is to act as the primary QA Liaison for the Sterile Manufacturing facility for marketed and investigational medicinal products. To work with Sterile Manufacturing to ensure the facility maintains compliance with GMP, ISO 13485, US Code of Federal regulations (21 CFR), Medicines Regulations 2021 as amended and internal procedures.

• Instigating, investigation and review of Quality Incidents and GMP deviations
• Regular Gemba walks of manufacturing units to ensure compliance with internal processes and regulatory standards
• Assisting microbiology with investigation and assessment of GMP deviations
• Review of Out of Specification (OOS) results
• Review, instigation and investigation of Customer Complaints including client liaison for these
• Tracking and close out of CAPA actions
• Tracking and review of Effectiveness checks
• Instigating, review and approval of Change Controls
• Performance of Internal audits from scheduling to close out, including working with Department Heads to agree appropriate actions to address findings
• Undertaking and coordinating training sessions
• Review and update of SOPs
• QA Review of Batch Manufacturing and Packaging Records for medical devices and Aseptic Process Simulations
• Coordination of the New Product Introduction Process for Sterile Manufacturing
• Hosting Client audits and assisting with Competent Authority and Notified body audits of the Sterile Manufacturing facility. Responding to Client audit report findings having agreed appropriate CAPA with Department Heads
• Review and approval of label proofs for Sterile Manufacturing and NSCU

Quality Officer - Compliance and Process Support employer: [Employer hidden — view at passion-project.co.uk]

Join a dynamic and supportive Quality Assurance team where your expertise as a Quality Officer will be valued and nurtured. Our company fosters a collaborative work culture that prioritises compliance and continuous improvement, offering you opportunities for professional growth through training and development. Located in a state-of-the-art Sterile Manufacturing facility, we provide a competitive benefits package including a daily travel allowance, pension, and bonus scheme, making us an excellent employer for those seeking meaningful and rewarding employment.