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 analyze samples as per written approved methods and procedures.
6. Performing IPC testing (Hardness – Friability – disintegration - weight - leak test,…) .
7. Check and report about methods and procedures being followed during process he is supervising and insure proper timely documentation.
8. Document his own work (analysis, inspection or check) and include with batch record prior to delivery with relevant samples to DCC. JOB DESCRIPTION
9. Implementation of deviation and Participating in deviation investigations.
10. Checking and signing every step in the process batch record.
11. Responsible for compliance with quality integrated system for quality, environment, health and safety in relation with his job and duties.
12. Responsible for follow up the environmental monitoring.
13. Implementation of personnel hygiene.