Role & responsibilities
Execute production activities in sterile injectable manufacturing, including aseptic processing and filling operations.
Operate and monitor equipment such as vial washing machines, depyrogenation tunnels, autoclaves, aseptic filling machines, capping machines, lyophilizers, and visual inspection machines.
Ensure strict compliance with cGMP, SOPs, BMR/BPR, GDP, and data integrity requirements.
Perform line clearance, equipment cleaning, sanitization, and area preparation before production.
Monitor critical process parameters and ensure adherence to approved manufacturing procedures.
Complete batch manufacturing records (BMR), equipment logbooks, and production documentation accurately.
Coordinate with QA, QC, Engineering, Warehouse, and Validation departments for smooth production activities.
Participate in media fill, aseptic process simulation, equipment qualification (IQ/OQ/PQ),



process validation, and cleaning validation activities.
Support deviation investigations, root cause analysis, CAPA implementation, change control, and risk assessment.
Ensure compliance with environmental monitoring requirements and contamination control strategies.
Maintain production targets while minimizing rejection, wastage, and downtime.
Follow EHS guidelines and maintain a secure working workplace.
Participate in internal, customer, and regulatory audits (USFDA, EU-GMP, MHRA, WHO-GMP, etc.).

Preferred candidate profile :
Education: B.Pharm / M.Pharm / B.Sc. / M.Sc. (Chemistry, Microbiology, Biotechnology) or equivalent.
Experience: 37 years in sterile injectable manufacturing.

📌 Production Executive Baddi (India)
🏢 Acme Generics
📍 India