Assistant Manager Senior Executive - Quality Assurance

Job Description

• Monitoring of Contract manufacturers of North India region
• Quality Oversight at Contract manufacturing sites.
• Regional representative for North 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
  
  

• 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.
  
  

• B. Pharmacy
• M. Pharmacy
• Or any science graduate with relevant experience
  
  

• Thorough Knowledge of shop floor of OSD & Sterile formulations
• Handling of contract manufacturers