19 Aug
|
Acme Generics
|
Baddi
19 Aug
Acme Generics
Baddi
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 environment.
- 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)
🏢 Acme Generics
📍 Baddi