Job Description
Job Description
Key Responsibilities:-
Lead day-to-day operations on isolator-based cartridge filling lines- Ensure readiness of filling lines, line clearance, and coordination with QA/Engineering- Drive qualification & validation activities: equipment qualification, media fills, process simulations- Review batch documents, deviation investigations, CAPA, and change controls- Ensure in-process controls: fill volume, crimp integrity, torque, visual checks- Lead investigation teams for any filling-related process failures
Technical / Functional Skills:- Strong understanding of isolator/RABS-based filling systems- Expertise in qualification activities: URS, DQ, IQ, OQ, PQ- Hands-on knowledge of media fills, VHP cycles, and glove integrity testing- Understanding of CCS (Contamination Control Strategy) requirements- Able to interpret SCADA/BMS/HMI data for troubleshooting
Behavioral Competencies:- Strong leadership and decision-making abilities- Excellent communication and stakeholder management- High compliance and documentation discipline
InjectablesSpecific Expectations:- Experience handling cartridge filling lines in isolator environment- Understanding of regulatory expectations (USFDA, EMA, WHO)- Ability to lead validation and requalification cycles
Qualifications
Experience: 1012 Years (Sterile Injectables)
Qualification: B.Pharm / M.Pharm (Mandatory)
