Job Description
Job Description
Key Responsibilities:-
Act as Shift In Charge ensuring smooth operation across manufacturing blocks- Allocate manpower, manage shift schedules, and ensure compliance to SOPs- Oversee readiness of filling/compounding areas, equipment, logbooks, and materials- Lead equipment qualification & validation activities during shifts- Review and verify BMR entries, logbooks, and ensure data integrity compliance- Perform real time troubleshooting for process deviations and escalate when required- Coordinate with QA, Engineering, and Warehouse during shift operations- Ensure production targets, shift KPIs, and compliance metrics are met- Ensure adherence to safety protocols, gowning, and cleanroom discipline
Technical / Functional Skills:- Hands on experience in filling or batch manufacturing operations- Strong understanding of isolator/RABS systems or compounding vessels- Expertise in qualification and validation (IQ/OQ/PQ, media fill, SIP validation)- Knowledge of SCADA/BMS/HMI systems and equipment troubleshooting- Understanding of contamination control strategy (CCS)
Behavioral Competencies:- Leadership, decision-making, and team handling capability- Strong communication and cross functional coordination- High integrity and disciplined documentation behavior
InjectablesSpecific Expectations:- Experience in sterile injectables mandatory- Capability to lead validation and qualification activities independently- Ability to manage full shift operations including manpower and output
Qualifications
Experience: 810 Years (Sterile Injectables)
Qualification: B.Pharm / M.Pharm (Mandatory)
