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 public

Qualifications:

• 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)