Quality Assurance Manager

Job Description Job Description Primary Responsibilities: Maintains and creates appropriate validation/Qualification- SOPs, files and Coordinates all quality activities with outside laboratories and partners including AmbioPharm. Ensure decisions made meet external and internal Quality compliance expectations for API and finished Communicate and coordinate with other departments and/or key stake-holders as required to resolve issues and concerns detected during review, assure issues are appropriately documented, investigated, corrections and preventative actions implemented, effectiveness evaluated, and trended for periodic Ensure quality systems are compliant and efficient at all contract manufacturers Actively participate in all the FDA related PAI preparation onsite and at the CMOs/CDMOs as required. Implement and maintain Corrective and Preventative Action (CAPA) To assist with the evaluation of planned changes (change control) to validated processes, equipment, procedures and organize re-qualification/re-validation studies where To assist with the review of validation protocols and reports for processes, equipment and computerized systems Ensure the implementation of effective corrective and preventative actions arising from QA monitoring/ inspection To maintain tracking for deviations, corrective and preventative actions, service complaints and change controls To assist with the investigation of result and complaints and ensure that effective immediate follow up actions are To perform internal audits against defined quality performance measures and ensure that effective immediate follow up actions are Manage or assist in external inspections and verify the completion of corrective action as required by the reports of the inspectors To assist with the management of quality documentation and the review and approval of all quality documents, e.g. SOPs To interact with personnel from other sections on any issues that may arise To respect information obtained in the course of duties performed, and refrain from disclosing such information without the consent of the employee/patient, or person entitled to act on their behalf, except where disclosure is required by law or by the order of a Court, or is necessary in the publicQualifications: Fundamental knowledge of drug product compliance principles 5+ years experience in the pharmaceutical industry, in a QA role A good understanding of auditing principles Proficient in the use of Microsoft (Access, Excel, Word)