Senior Quality Assurance Engineer

QA Senior Engineer, Inspection, Labelling and Packaging

This is a unique opportunity to join the Quality Assurance team of a global CDMO specialising in parenteral injectable drug products, in a highly visible role that directly supports the delivery of safe, effective products to patients worldwide. Reporting to the QA Director of Quality Systems, you will be part of a collaborative, fast-paced environment where your expertise in inspection, labelling, packaging and serialisation quality systems will shape the future of the organisation's CDMO operations.

The QA Senior Engineer of Inspection, Labelling and Packaging is responsible for the oversight and continuous improvement of quality systems governing finished product inspection of aseptically filled vials, syringes and cartridges, as well as labelling, packaging and serialisation operations. This role ensures that all associated quality systems are designed, implemented and maintained in a state of regulatory compliance with FDA, EMA and other applicable regulatory requirements.

The QA Senior Engineer serves as a subject matter expert (SME) and key quality partner to Manufacturing, Technical Services, Engineering and Supply Chain teams, driving operational excellence and inspection readiness across all inspection, labelling and packaging activities.

• Provide quality oversight and SME support for finished product visual inspection operations, including manual, semi-automated and automated inspection of filled vials, syringes and cartridges
• Own and manage quality systems related to labelling, packaging and serialisation, ensuring compliance with FDA and EMA regulations, USP/ISO/ICH/PDA/ISPE and other non-governmental guidance documents, and applicable serialisation regulations (e.g. DSCSA)
• Author, review and approve SOPs, work instructions, batch record sections and specifications related to inspection, labelling, packaging and serialisation processes
• Lead or support deviation investigations, root cause analyses and CAPA activities related to inspection defects, labelling errors, packaging failures and serialisation events
• Collaborate with Manufacturing, Engineering and Technical Services to develop and qualify inspection parameters, AQL criteria and defect libraries for new and existing products
• Ensure inspection, labelling and packaging quality systems maintain audit and inspection readiness for FDA, EMA and client audits
• Oversee process validation activities for inspection equipment, labelling systems, packaging lines and serialisation/aggregation systems
• Review and approve change controls, risk assessments and validation protocols/reports impacting inspection, labelling and packaging operations
• Support QA floor oversight as an SME for escalations during inspection, labelling and packaging operations
• Stay current with evolving regulatory expectations and industry best practice for parenteral product inspection, labelling, packaging and serialisation

• Bachelor's degree in a scientific, engineering or technical discipline (e.g. Biology, Chemistry, Pharmaceutical Sciences, Engineering) required, or 10+ years' experience in a Quality and/or Engineering role with similar responsibilities in lieu of a degree
• Minimum of 5 years' experience in pharmaceutical or biopharmaceutical Quality Assurance, with direct experience in developing and maintaining site or corporate level quality systems for finished product inspection, labelling, packaging and serialisation operations
• Minimum of 3 years' experience in a GMP-regulated parenteral/sterile injectable manufacturing environment
• Demonstrated knowledge of FDA regulations (21 CFR Parts 210, 211), EU GMP Annex 1, ICH guidelines, inspection guidance (USP and ),…