Quality Assurance Manager

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