Senior Manager - Quality Assurance

Job Description:

Responsibilities

• Releasing or rejecting all APIs including intermediates
• Ensuring the compliance of all the systems as per GMP requirement
• Approving all specifications and master production instructions
• Investigation and closure of all deviations & OOS
• Approving all procedures affecting quality of RM/IM/API
• Conducting self-inspections and internal audit
• Conduction vendor evaluation
• Review of changes that potentially impact intermediates or API Quality
• Reviewing of validation protocols and reports
• Investigation of quality related customer complaints and returned goods
• Review of preventive maintenance and calibration of equipment's
• To execute Risk Assessment Activity
• Review of stability data
• Performing product quality review
• Facing customer and regulatory audits
• Ensuring proper responses to the customer and regulatory queries
• Checking of QA procedure
• In absence of Head-QA, will be responsible for QA related activities