As a result of ongoing expansion projects, our client is seeking an experienced Quality Assurance Specialist. This is a unique opportunity to play a key role in a high-impact project, providing QA oversight for operational readiness, validation, and technology transfer activities supporting the introduction of new component combinations and aseptic filling operations.
This role will ensure quality and compliance across integrated line qualification, media fill execution, and product introduction activities, working closely with Engineering, Operations, and Process Development teams.
Key Responsibilities
1. Operational Readiness, Validation & Documentation
* 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.
2. Technology Transfer & New Product Introduction (NPI)
* 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.
3. Quality Systems, Risk Management & Compliance
* 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.
Qualifications & Experience
Education:
* Bachelor's or Master's degree in Science, Engineering, Biotechnology, or related discipline.
Experience:
* 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).
Key Competencies
* 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.
