Job Details

Job description OVERSIGHT Implementation, execution and maintenance of internal auditing program Develop, author and maintain protocols for qualification, validation, recertification and preventative maintenance of primary/ secondary process equipment, utilities and processes. General oversight of CAPA program, documentation and CAPA implementation Review and approval of annual product review. Review and approval of environmental trending data. General oversight of batch record generation, revision, issuance and review RESPONSIBILITIES compliance to cGMP regulations applicable to 503(b) Outsourcing Facilities requirements Compliance to SOP and quality systems Author, revise and train on SOP protocols and reports Participate and contribute to the controlled document, change control, deviation, complaints and investigation quality systems Ensure processes and products are appropriately validated Monitor that equipment PM and calibrations are completed within required time frames Support the company functions involved in cGMP activities to build a culture based on problem solving