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Walker Cole International is searching for a QA Contractor to support a leading Biologics manufacturing company based in the North of the UK. As a QA Contractor, you will play a key role in ensuring GMP compliance across the site, supporting day-to-day quality operations and documentation activities specific to biologics production with a focus on Quality Operations.
As the QA Contractor you will be responsible for:
Reviewing and approving GMP documentation including batch records, deviations, CAPAs, and change controls related to biologics manufacturing processes.
Supporting the QA team with routine quality checks and compliance activities tailored to aseptic and biologics production environments.
Assisting in the investigation and resolution of quality issues in collaboration with cross-functional teams including manufacturing, QC, and validation.
Contributing to audit readiness and supporting internal and external audits focused on biologics compliance requirements.
Ensuring all activities are carried out in accordance with current GMP standards, with a strong focus on biologics and aseptic processing regulations and company procedures.
The successful candidate for the QA Contractor role must have:
A degree in Life Sciences or a related field.
Previous experience in a GMP-compliant biologics or aseptic pharmaceutical manufacturing environment.
Solid understanding of Quality Assurance principles and regulatory expectations specific to biologics production.
Ability to work independently and manage priorities in a fast-paced environment.
Strong attention to detail and excellent communication skills.
QA Contractor | Quality Assurance | GMP | Biologics | Aseptic Manufacturing | Batch Review | CAPA | Deviation Management | Change Control | QA Officer | QA Specialist | Pharmaceutical Manufacturing | QA Compliance | Quality Systems