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Job #02552

About our client Our client is a chief manufacturer of therapeutic peptides for pharmaceutical and biotech companies. The company carries out its operations from two different locations one in Brussels, Belgium and the other in Torrance, California. They produce cGMP peptides according to the most stringent regulatory requirements based on a strong quality assurance policy. Position Location Quality Assurance and Regulatory Affairs Manager Southern California Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee the QA Department 2) Review and release finished product(s) 3) Oversee daily activities of the Quality Assurance Department 4) Review and approve the quality controlled finished product data files, notebooks and production completed batch records for release of the final bulk drug substance 5) Correspond to customer’s requests for product shipment, documentation information, product and company regulatory status and customer audit responses 6) Perform internal audits and writing reports for process, equipment, facility, procedures, logbooks and training files 7) Create/revise SOPs for sections A, B, C, E, F, G, H and J 8) Ensure the proper implementation and application of SOPs 9) Establish and maintain document control 10) Train employees on regulatory requirements and general SOPs 11) Investigate non-routine high-priority items as delegated by Vice President, Operations 12) Create chemistry manufacturing control documentation packages for customer filings and drug master files for phase III clinical trial products 13) Create, review and approve deviations, investigations and out-of-specification reports 14) Provide or approve corrective and preventive actions for deviations, investigations and out-of-specification reports 15) Evaluate the performances of QA personnel 16) Perform related duties (as assigned) 17) Approve/reject finished bulk drug substances based on the review of batch records and quality control testing files 18) Suggest or approve all corrective and preventive actions to prevent a problem from recurring 19) Approve or reject standard operating procedure, deviations, investigations and out-of-specifications Requirements 1) College degree 2) 2-3 years of managerial experience 3) 5 years of related experience in quality assurance for a pharmaceutical company 4) 2-3 years of experience in regulatory affairs 5) Training experience preferred 6) Knowledge of cGMP regulations, especially, 21 CFR Part 211