Quality Assurance Specialist

Team Horizon is seeking an experienced Quality Assurance Specialist 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.

Why you should apply:

• This role is an excellent opportunity because it places you in a influential QA position where your expertise directly shapes the quality and compliance of aseptic drug products that reach patients worldwide.


• You’ll act as a key quality decision-maker for new product introductions, tech transfers, and process validation giving you real ownership, visibility, and impact across the, site.


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What you will be doing:

• 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.


• 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 standards and cGMP.


• 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 global validation and quality system standards.


• 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

What you need to apply:

• 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 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).