Job Description
Key Responsibilities:-
Lead entire manufacturing line during shift, covering filling, compounding, sterilization, and support areas- Drive execution of shift production plan, monitor OEE, yield, and critical KPIs- Ensure MES compliance: batch initiation, electronic logbook completion, exception handling, and e records accuracy- Approve batch steps electronically in MES where authorization hierarchy allows- Coordinate with QA, Engineering, Warehouse, and Utilities for seamless shift functioning- Perform real time troubleshooting, lead deviation triage, ensure documentation of events- Ensure equipment qualification/validation readiness and support PQ/verification activities- Lead shift review meetings, manpower allocation, and adherence to safety and gowning discipline- Ensure data integrity compliance across MES, SCADA, BMS and paper records
Technical / Functional Skills:- Strong hands on experience with MES (Manufacturing Execution System) operations- Expertise in qualification & validation (IQ/OQ/PQ, media fill, SIP validation, filtration validation)- Understanding of isolator/RABS filling lines, compounding vessels, and sterilization equipment- Knowledge of SCADA/BMS/MES interfaces and troubleshooting- Strong command of cGMP, Annex 1, and data integrity principles (ALCOA+)
Behavioral Competencies:- Strong leadership and decision making under pressure- Excellent communication and cross functional collaboration- High sense of ownership, discipline, and integrity
InjectablesSpecific Expectations:- Experience leading full shift manufacturing operations in sterile injectables- Ability to oversee qualification, validation, and readiness of all unit operations- Proficiency in MESbased batch execution and exception handling
Education
QUALIFICATIONS
- Bachelors Degree (BA/BS) B. Pharm - Required
- Master Degree (MS/MA) M. Pharm - Preferred
Experience
- 10 years or more in 10 - 15 Yrs
