- Coordinate and performs batch record disposition of development, finished products and raw materials
- Review deviations, CAPA’s, change controls, and any other site/product related documents adequate levels of documentation are adequate and compliant to existing procedures
- Drive continuous improvement and enhancement efforts to the disposition process to ensure an efficient yet compliant process is maintained
- Support regulatory agency inspections, by way of auditing, training and preparation, and tracking commitments
- Support maintenance of central file correctives and inspection history
- Write and review policies, Standard Operating Procedures (SOPs) and associated processes/guidelines
- Provide support to the investigation process and follow-up to assure timely discrepancy closure
- Participate in the internal audit program
- Assist in revision of SOP’s for all departments
- Ensure strict adherence to Standard Operating Procedures and GMP principles
- Act as backup person for the inspectors by checking in-process testing done by production technicians by performing tests, reviewing test data, filling in the manufacturing and packaging batch records and writing investigations according to SOPs and GMPs.
- Bachelor’s degree in Pharmacy or Pharmacology or its equivalent.
- Previous experience in Pharmaceutical Manufacturing and QA role is an advantage.
- Exposure and hands-on different roles at different manufacturing disciplines (e.g. Production Inspector, Quality Control, Engineering) is a definite plus.
For Interested Applicants you can send your application at email@example.com