QA Specialist

• Provide QA leadership duringdesign of new rooms, development of materials/people/waste flows and contamination controls (gowning, cleaning, desinfection)ensuring operational robustness. QA review/approve associated risk assestments and SOP.

• Review and approve validation documentation including integrated line PQs, media fills, and environmental monitoring qualifications.

• Support QA review of MBR and recipe creation for filling, lyophilisation, and associated aseptic operations.

• Ensure readiness of operational documentation including SOPs, batch records, and contamination control strategies.

• Contribute to the review of contamination control, isolator qualification (including smoke studies and VHP qualification), and environmental monitoring performance qualification (EMPQ).

• Maintain oversight of validation and readiness documentation to ensure it is audit-ready, scientifically sound, and compliant with client standards and cGMP.

• Serve as the QA Lead for technology transfer and NPI activities, providing quality oversight throughout process validation and product lifecycle introduction.

• Review and approve technology transfer documentation including process descriptions, PPQ protocols, validation reports, and risk assessments.

• Partner cross-functionally with Technical, Engineering, and Operations teams to ensure all NPI activities are compliant with regulatory and site quality requirements.

• Ensure alignment of transfer activities with the clients global validation and quality system standards.

• Lead and support deviation, CAPA, and change control management related to operational readiness, validation, and tech transfer activities.

• Conduct quality risk assessments for new processes, interventions, and aseptic operations.

• Ensure data integrity and right-first-time execution across all readiness and validation deliverables.

• Support inspection readiness and regulatory audits, representing QA for validation and NPI areas.

• Bachelor's or Master's degree in Science, Engineering, Biotechnology, or related discipline.

• Minimum 8 years' experience in pharmaceutical or biotechnology manufacturing

• Proven expertise in facility startup and Quality Oversight of Operational Readiness and and technology transfer activities.In-depth knowledge of applicable regulatory requirements and experience with regulatory inspections including EU/FDA GMP, Annex 1, and process validation lifecycle requirements.

• Experience working in aseptic operations, relating to vial and syringe filling.

• Experience managing change control, deviations, and CAPAs through electronic QMS systems (e.g., TrackWise, Veeva Vault, PAS-X, SAP).

• Strong technical understanding of aseptic manufacturing and validation.

• Excellent collaboration, communication, and decision-making skills.

• Analytical and pragmatic approach to quality risk management.

• Ability to balance regulatory compliance with operational efficiency.

Morgan McKinley