Job Description
Job Description
Key Responsibilities:-
Supervise end-to-end operations on isolator-based cartridge filling, stoppering, and capping lines- Ensure batch readiness: component availability, line clearance, and area readiness in Grade C background- Execute/monitor VHP bio-decontamination cycles, leak tests, and glove integrity testing (GIT)- Oversee line setup/teardown, sterilized format parts handling, and aseptic connections via RTPs/ports- Monitor IPC checks (fill volume, weight, torque, crimp integrity) and document results in BMR- Coordinate with QA/Engineering for alarms, troubleshooting, and timely line restarts- Lead media fill preparations and execution support; ensure adherence to Annex 1 and site procedures- Review logbooks/BMRs, ensure ALCOA-compliant entries, and support deviations/CAPA- Ensure EM support during operations with minimal interventions- Drive continuous improvement in setup time, first-pass yield, and reject reduction
Technical / Functional Skills:- Hands-on experience with isolators or closed RABS cartridge filling lines- Working knowledge of VHP cycles and material transfer via pass-throughs- Knowledge of GIT, pressure differentials, airflow visualization, and Grade A unidirectional flow- Understanding of washer, depyrogenation tunnel, filling machine, stopper/capper systems- In-process controls: fill weight/volume checks, container closure integrity fundamentals- Strong grasp of cGMP, EU GMP Annex 1, US FDA expectations, and ALCOA+
Behavioral Competencies:- Ownership, discipline, and a strong compliance mindset- Ethical behavior and accurate documentation- Clear communication and leadership on the floor
InjectablesSpecific Expectations:- Proven aseptic behavior in Grade A/B environments- Experience with media fills and CCS requirements- Capability to perform aseptic interventions inside isolator
Qualifications
Experience: 35 Years (Sterile Injectables)
Qualification: B.Pharm / M.Pharm
