Job Details

Quality Assurance Specialist

Responsibilities: Under general supervision, maintains Quality Assurance System to ensure compliance with company and cGMP standards. Responsible for maintaining audit program, reviewing functional and release documentation and investigating deviations relevant to area of responsibility. Reviews lot release documentation and facilitates compliant release process for corresponding market. Responds to questions from authorities (Swissmedic, FDA, etc.) to ensure timely product release. Ensures standard operating procedures (SOP's) stay current and align with corporate and regulatory requirements. Executes training/awareness related to GMP standards.

Qualifications: University degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry). 3+ years' GMP experience in pharmaceutical/biotech or other regulated industry. Knowledge of current Good Manufacturing Practices (cGMP) principles. Knowledge of FDA and EMA requirements. Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.