Responsibilities: • Responsible for supervising daily activities of the QA team to ensure compliance with company and cGMP standards • Ensures compliance with established internal specifications, standard operating procedures (SOP) and government regulations • Maintains records of incoming material inspection and disposition and represents department in evaluating quality concerns with suppliers • Establishes and maintains a system for ‘in time’ review of batch records and preparation of release certificates for all market regions • Manages submission of test samples, certificates and batch documentation for authorities (Swissmedic, FDA, etc.) to ensure timely product release • Ensures standard operating procedures (SOP’s) stay current and align with corporate and regulatory requirements Qualifications: • Bachelor degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry) • 5 years' GMP experience in pharmaceutical/biotech/or other regulated industry • Leadership/ team management skills • 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.
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