Job Summary
The IPQA Chemist is responsible for monitoring and ensuring compliance of manufacturing and packing activities as per GMP, SOPs, and regulatory requirements during the production process. The role involves in-process checks, line clearance, documentation review, sampling, and maintaining quality standards on the shop floor.
Key Responsibilities
- Perform IPQA activities during manufacturing and packing operations.
- Conduct line clearance before starting production and packing activities.
- Verify cleanliness of equipment, area, and machines.
- Monitor dispensing, manufacturing, filling, and packing processes.
- Ensure compliance with cGMP, SOPs, and safety procedures.
- Review Batch Manufacturing Records (BMR) and Batch Packing Records (BPR).
- Perform in-process checks and sampling activities.
- Check environmental conditions such as temperature, humidity, and differential pressure.
- Report deviations, incidents, and non-conformances to QA Head.
- Ensure proper online documentation and data integrity.
- Coordinate with Production, QC, and Warehouse departments.
- Assist during internal, customer, and regulatory audits.
- Maintain records related to IPQA activities.
- Ensure proper status labeling and material identification.
- Monitor gowning and personnel hygiene practices in production areas.
Required Skills
- Knowledge of GMP, GLP, and GDP
- Good documentation practices
- Knowledge of pharmaceutical manufacturing process
- Attention to detail
- Good communication and teamwork skills
- Problem-solving ability
- Basic knowledge of regulatory requirements
Preferred Knowledge
- Handling of injectable / oral / topical manufacturing
- Process validation and cleaning validation
- Regulatory audit exposure
- Knowledge of aseptic area practices
Working Conditions
- Shop floor monitoring in manufacturing areas
- Rotational shifts if required
- PPE and GMP compliance mandatory
Key Performance Indicators (KPI)
- Compliance with GMP standards
- Reduction in deviations and market complaints
- Timely completion of IPQA activities
- Audit readiness and documentation accuracy
Pay: ₹12,000.00 - ₹14,500.00 per month
Work Location: In person
