Senior Executive- Filling Inj Manufacturing
Core
Ensuring compliance and operational integrity in sterile injectable manufacturing through document control, line clearance, and equipment monitoring.
Role type
Senior IC manufacturing operations specialist (sterile fill-finish)
Builds
Injectable pharmaceutical products
Domain
Pharmaceutical manufacturing (sterile/aseptic)
Required skills
Filling, stoppering, and sealing; Equipment operation and cleaning (CIP/SIP); Dispensing; Sterilization through Autoclave; Mixing; Decartoning; Washing; Terminal Sterilization; Good Manufacturing Practice (GMP); Batch documentation and record review; Cleaning and line clearance; People management and team leadership
Preferred skills
None stated
Technologies
None stated
Responsibilities
Manage document control (BMRs, BPRs, SOPs); Prepare and review master production documents; Ensure UAF working; Handle change control, deviations, investigations, and CAPA; Train subordinates, technicians, and operators; Perform line clearance before operations; Check records and logbooks for aseptic manufacturing, vial filling, and sealing; Ensure cleaning and sanitization of General, Controlled, and Aseptic areas; Monitor activities in General, Control, and Aseptic areas; Ensure qualification and calibration status of equipment; Ensure scheduled activities of area/equipment/instruments; Attend training as per schedule.
Seniority
Senior, hands-on IC