Executive – Fill Finish Facility

Lupin Ltd; Pune District; On-site; INR 900,000 - 1,100,000; Full time

Job summary

Lupin Ltd in Pune, Maharashtra, invites an experienced professional to execute and supervise sterile formulation and compounding activities in accordance with BMR/BPR and cGMP requirements.

The role covers autoclave operations, aseptic processing, in-process checks, real-time documentation, equipment cleaning, CAPA handling, and coordinating with QA and Engineering for timely maintenance and issue resolution.

Qualifications

• Experience with autoclaves and sterile manufacturing
• Knowledge of BMR/BPR and aseptic GMP
• Regulatory plant experience (USFDA and EMA) preferred

Responsibilities

• Execute and supervise sterile formulation and compounding per BMR/BPR.
• Plan and carry out dispensing, formulation, filtration and material transfer per cGMP.
• Perform in-process checks and maintain real-time documentation for data integrity.
• Operate and monitor autoclaves and review cycle parameters and printouts.
• Handle autoclave alarms, deviations and CAPA investigations and corrective actions.
• Wash and clean equipment using automatic and manual systems per procedures.
• Verify cleanliness, labeling, release, and storage of washed items.
• Coordinate with Engineering and QA for troubleshooting and timely resolution.
• Coordinate batch planning and routine PM, calibration, and AMC activities.

Skills

Sterile formulation

Autoclave operations

Aseptic processing

cGMP compliance

Documentation

CAPA handling

QA coordination

Education

Bachelor's degree in Pharmacy or Biotechnology

Tools

Autoclave equipment

Washing systems

Job description

Job Description

Execute and supervise sterile formulation and compounding activities in accordance with approved Batch Manufacturing Records (BMR) and Batch Processing Records (BPR).

Plan and carry out dispensing, formulation, filtration, and material transfer activities in compliance with cGMP requirements and aseptic practices.

Perform in-process checks, monitor critical process parameters, and maintain accurate, real-time documentation to ensure data integrity throughout formulation operations.

Operate and monitor autoclaves for sterilization of equipment, components, garments, and materials as per approved SOPs and validated sterilization cycles.

Load and unload autoclaves according to validated load patterns and review cycle parameters, printouts for compliance.

Handle autoclave alarms, deviations, and cycle failures through proper investigation, documentation, and implementation of corrective and preventive actions (CAPA).

Perform and supervise washing and cleaning of equipment, components, and accessories using automatic and manual washing systems as per approved procedures.

Verify cleanliness status, labeling, release, and proper storage of washed items while ensuring segregation as per classified cleanroom area requirements.

Conduct routine equipment checks, identify abnormalities, and coordinate with Engineering and Quality Assurance for timely troubleshooting and resolution.

Co-ordination with CFT for batch planing and routine sceduled activities like PM, calibration and AMC related to assinged area.

Work Experience

6-8 years (with hands-on experience in Autoclave, Formulation, and Washing Area). candidate shoud have regulatory plant experiance USFDA and EMA.

Education

Graduation in Pharmacy or Biotechnology