Quality Assurance Specialist
Key Responsibilities:
* Review and approve batch records for Cell Culture and Purification operations to ensure cGMP compliance.
* Assist with QA documentation management, issue resolution, and efficiency metrics.
* Support change management, deviations, CAPA systems, and batch release reviews.
* Help with site risk management and maintenance of the Electronic Quality Management System.
* Provide QA support to Quality Control, including reviewing raw data, non-conformance reports, and deviations.
* Contribute to site training, deliver modules as needed, and assist in vendor management (assessments, audits, qualifications).
* Support internal and external audits, prepare Quality agreements.
* Assist with data integrity projects, equipment qualification, and setting up new electronic systems.
* Oversee product and cell bank stability programs, including sample submission and result filing.
Requirements:
* Bachelor's degree in Science or related field.
* At least 2 years experience in a pharmaceutical environment.
* Able to prove right to work in the UK or Republic of Ireland.
Benefits:
* Work From Home option.
* Pension plan.
* Healthcare benefits.
* Bonus scheme.