The ideal candidate is a critical thinker who will proactively improve the quality systems of the company through internal audits, participation in process improvement programs, and interaction with key partners to obtain constructive feedback.
Responsibilities
- Quality Oversight at Contract manufacturing sites.
- Regional representative for Rest of India for overall Quality compliance
- FG Inspection, Review of batch records and Batch releases
- Review of Finished product related data to support new Third Party Launch
- IPQA - Tablets, Capsules, Oral Liquids, External and Sterile formulations etc.
- Monitoring of all shop floor activities covering OSD, Oral Liquid, External and Sterile products.
- Process Validation and Stability study execution and data review
- APQR preparation, Witness manufacturing and analysis of finished product.
- Quality Audits of Contract Manufacturers & compliance review
- CMO Management & co-ordination
- Preferred Candidate: Candidate should have good exposure to GMP environment and regulatory inspections.
- Candidate should be flexible for business travelling across India & Overseas Locations
- Candidates working on Shop floor and should have good GMP/GLP exposure.
- Independent and Candidates who able make to decisions online.
- Cross functional working and good ability to communicate with external stakeholders.
Qualifications
- B. Pharmacy
- M. Pharmacy
- Or any science graduate with relevant experience
- Thorough Knowledge of shop floor of OSD & Sterile formulations
- Handling of contract manufacturers
