Responsibilities

1. Review and approve batch records for Cell Culture and Purification operations to ensure cGMP compliance.
2. Assist with QA documentation management, issue resolution, and efficiency metrics.
3. Support change management, deviations, CAPA systems, and batch release reviews.
4. Help with site risk management and maintenance of the Electronic Quality Management System.
5. Provide QA support to Quality Control, including reviewing raw data, non-conformance reports, and deviations.
6. Contribute to site training, deliver modules as needed, and assist in vendor management (assessments, audits, qualifications).
7. Support internal and external audits, prepare Quality agreements.
8. Assist with data integrity projects, equipment qualification, and setting up new electronic systems.
9. Oversee product and cell bank stability programs, including sample submission and result filing.

Requirements

1. Bachelor's degree in Science or related field.
2. At least 2 years of experience in a pharmaceutical environment.

Skills:
pharmaceutical, quality, GMP, documentation

Benefits:
Work From Home, pension, healthcare, bonus