Executive – Fill Finish Facility

Lupin; Pune District; Vor Ort; INR 1.200.000 - 1.800.000; Vollzeit

Zusammenfassung

Lupin is seeking an experienced professional for sterile formulation activities in Pune. Responsible for autoclave operation, formulation, washing, and documentation to ensure data integrity in a compliant environment.

The role requires 6–8 years of hands-on experience in autoclave, formulation, and washing areas with regulatory plant experience (USFDA/EMA) and a Pharmacy or Biotechnology degree.

Qualifikationen

• 6–8 years hands-on experience in autoclave, formulation, and wash area.
• Regulatory plant experience USFDA and EMA.
• Graduation in Pharmacy or Biotechnology.

Aufgaben

• Execute and supervise sterile formulation and compounding per BMR/BPR.
• Plan dispensing, formulation, filtration, and material transfer per cGMP and aseptic practices.
• Perform in-process checks and monitor critical parameters with real-time documentation.

Kenntnisse

Autoclave handling

Formulation

Washing & cleaning

GMP compliance

Data integrity

Ausbildung

B.Pharm/Bachelors in Pharmacy or Biotechnology

Jobbeschreibung

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

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