Production Operator

Role & responsibilities

1. Should have thorough knowledge on the operations of production equipment such as Blow Fill Seal (BFS), Terminal Sterilizer, Vessels, Ampoule filling line, vial filling machine with Isolator etc.
2. Shall involve in the installation and operations equipment/ instrument as when required.
3. Shall review the equipment design for its product requirements, GMP perspective and performance.
4. Shall prepare the URS for production equipment / instrument (if required).
5. Shall be responsible for initiation, identification, evaluation of procurement of miscellaneous items required for production operation.
6. Shall be responsible for initiation, identification, evaluation of procurement of small instruments / apparatus required for production operation.
7. Shall involve and support for initial and followed by routine equipment, facility, utility& process qualification.
8. Shall be responsible to maintained overall CGMP in all operation/s.
9. Shall be responsible for Production QMS notification initiation and closure by ensuring:
1. Design error detection and prevention by using root cause analysis (specifically the "5 Whys") to identify and eliminate recurring sources of defects.
10. Shall be responsible for improving productivity of the area/ equipment by reducing downtime, to improve the overall equipment effectiveness (OEE) by ensuring:
1. Involvement in maintaining their own equipment while emphasizing proactive and preventive maintenance techniques following, I OWN, I MAINTAIN, I OPERATE philosophy that will lead to, zero (0) breakdowns, no stops or running slowly, No defects and no accidents (Autonomous Maintenance)
2. Routine primary maintenance like Cleaning, Lubricating and Inspection, Tightening and Adjustments (CLITA).
11. Shall be responsible for Production execution and timely completion of targets.
12. Shall ensure that all logbooks, BMR & BPR are filled, closed on time and to initiate any deviation if the results are not within the acceptance criteria within the stipulated time.
13. Shall be responsible for component preparation, compounding, sterile filling& closing operation.
14. Shall be responsible for inventory of consumables.
15. Ensure production goals / target to archived within timeline.
16. Shall be accountable for timely completion of SOP and CGMP training.
17. To ensure Safety norms as per EHS policy of the site, meet 100% guidelines.