Senior Quality Specialist

Job Overview :

Achieve business objectives by collaborating with the Quality Assurance and Regulatory Affairs Department. Cooperate in compliance with implemented policies and procedures.

Prepare and review deviation reports, change controls, risk assessments, corrective actions, and other documents that require quality assurance oversight.

Support audits of clients and regulatory authorities.

• Review documentation for GMP lots and Cellular Bank batches.
• Prepare stability studies, including protocol and report reviews.
• Issue quality system documentation to facilitate departmental activities.
• Review Process Verification and Cleaning Verification.
• Prepare Product Quality Reviews and review product specifications.

Bachelor's degree in a relevant discipline is required. Previous experience working in a CDMO environment is desirable. 5 years of experience in quality assurance roles is essential. Expertise in GMP regulations is necessary. Fluency in English is desirable.