1.Check machine/line for clearance as per written approved procedures before the start of batch manufacturing.
2. Periodically inspect the manufacturing Areas for appropriate cGMP compliance.
3. Ensuring that all steps of operation on department are done as its requirement.
4. Give start up or release for machine/line so as to start manufacturing after making sure that all procedures have been properly followed and that there are no deviation(s) from cGMP rules and/or written procedures.
5. Collect samples from batch being manufactured as per written sampling procedures and test, examine or analyse samples as per written approved methods and procedures.
6. Performing IPC testing (Hardness – Friability – disintegration - weight - leak test,…).
Proven work experience as a Quality Assurance Specialist or similar role in a pharmaceutical industryWorking knowledge of tools, methods and concepts of quality assuranceSolid knowledge of relevant regulatory standardsGood communication skills, both verbal and writtenExcellent data collection and analysis skillsMales only according to current work needsRelevant training and/or certifications as a Quality Assurance Specialist