Job Description

Key ResponsibilitiesProduction Operations

Plan and execute day-to-day production activities for

LVP (IV fluids) and SVP (ampoules, vials, BFS, PFS, etc.)

. Ensure adherence to approved

batch manufacturing records (BMRs/BPRs)

. Achieve production targets with optimum utilization of

manpower, machines, and materials

. Monitor critical process parameters during

washing, sterilization, filling, sealing, and terminal sterilization

.
Compliance & Quality

Ensure compliance with

cGMP, GLP, GDP, and regulatory guidelines

(USFDA, EU-GMP, WHO, MHRA, etc.). Participate in

regulatory inspections, audits, and customer audits

. Ensure proper documentation, data integrity, and good documentation practices (GDP). Handle

deviations, CAPA, change controls, OOS/OOT investigations

related to production.
Equipment & Facility Management

Ensure proper operation, cleaning, and maintenance of

sterile manufacturing equipment

(autoclaves, tunnels, filling lines, isolators, lyophilizers, etc.). Coordinate with Engineering for

preventive maintenance and breakdown handling

. Support equipment qualification and process validation activities.
Team Management

Lead, train, and develop production staff, supervisors, and operators. Ensure discipline, shift planning, and skill enhancement of the production team. Promote a culture of

quality, safety, and continuous improvement

.
Job Type: Full-time

Work Location: In person