Details: SR. QA COMPLIANCE ASSOCIATEJOB PURPOSE: Support activities of the company’s document control system including the filing, changing and distributing of all current Good Manufacturing Practices (cGMP) electronic and paper copy documents in a manner that satisfies the requirements of our clients and corporate expectations. JOB RESPONSIBILITIES: Returned Good Authorization program Environmental monitoring program Discrepancies program Prepare and monitor Internal Audit program Prepare and monitor Supplier Audit program Corrective and Preventive Action (CAPA’s ) Program Calibration program Review and approval of Manufacturing Batch Records Review and approval of executed packaging batch records Review stability results Support maintaining document controls files and records, including records retention Support Packaging component inventory control Support Inspections of packaging and labelling components Support Finished Goods inventory control cGMP Training for employees Support preparation of annual product reviews in compliance with FDA and EU regulations Release of product and ensure accurate status of product Sign Certificates of Analysis and/or Certificates of Conformance On-Site Document Approval Monitor DI’s, LI’s, CAPA’s, Customer Complaints Documentation errors and Change Controls (provide trend analysis) Support activities with US and International Regulations in conjunction with Registration department Support for the East and West cost distribution centers Perform release and rejection of lots Monitor Pest Program May perform special projects as requested by the Quality Assurance and Regulatory Compliance Manager.
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