Injectable Production / Manufacturing
Experience: 2 – 6 years
Qualification: Diploma/B-Tech (Engineering)—Minimum 60%
Skills/Expertise:
Handling PFS, Cartridges, B+S Liquid Vial, Compounding, and aseptic filling operations
Exposure to Isolators, Vial Wash, Tunnel, Lyophilizer, Autoclave
Experience with USFDA regulatory environment
Engineering
Experience: 4 – 8 years
Qualification: Diploma/B.Tech (Mechanical/Instrumentation) – Minimum 60%
Skills/Expertise:
Process area maintenance: Manufacturing vessels, Filling machine, Autoclave, Isolators, Lyophilization
Automation engineering in manufacturing and filling area
Electrical 33KV license (mandatory)
HVAC, Utility, Water systems, Instrumentation, Process control
Quality Control
Experience: 3 – 8 years
Qualification: M.Sc. – Minimum 60%
Skills/Expertise:
Handling HPLC, GC, KF Instrument, IR, UV, and Chemical Analysis
Working experience in a cGMP, emphasis on GDP (Good Documentation Practices)
Knowledge of stability
Experience with the USFDA regulatory environment)
Quality Assurance
Experience: 3 – 8 years
Qualification: B.Pharm/M.Sc. – Minimum 60%
Skills/Expertise:
Experience in QMS, Investigations, Risk assessment, deviations, change control, and CAPA
Line clearance activities, document review