Deputy Manager-Corporate Quality Assurance

Role & responsibilities

• Harmonize QA SOPs and formats of MSN API divisions into corporate procedures in line with global regulatory guidelines (ICH, 21 CFR, EU, WHO).
  
• Prepare and distribute CQA SOPs and formats to respective manufacturing sites.
  
• Ensure timely initiation and closure of change controls, including impact assessments and approvals by relevant departments and Head CQA.
  
• Monitor the implementation of established procedures across API manufacturing sites.
  
• Provide QA support during regulatory inspections at sites, as needed.
  
• Manage document control activities, including issuance, archival, retrieval, and retention of GMP documents.
  
• Issue GMP-related registers and reconcile records across departments.
  
• Identify gaps in existing procedures vs regulatory guidelines through internal CQA audits.
  
• Facilitate harmonization of best practices and compliance findings across all API units.
  
• Review and trend quality metrics including change controls, OOS, OOT, lab incidents, etc.
  
• Prepare and present data for Management Review Meetings (MRMs).
  
• Conduct internal audits and support external audits when required.
  
• Deliver training on cGMP, SOPs, on-the-job activities, and other quality systems.
  
• Ensure effective implementation of digitalization systems across QA operations.
  
• Facilitate validation, risk assessment, change management, and scaling of new/modified digital systems.
  
• Perform periodic audit reviews of digital systems and ensure compliance with data integrity standards.
  
• Escalate resource requirements for digital system operations and represent digital QA systems during audits.

Preferred candidate profile

• Sound knowledge of global regulatory requirements (ICH, WHO, EU GMP, 21 CFR Part 11, etc.)
  
• Strong documentation and quality systems management skills.
  
• Experience in handling digital QA systems and document management platforms.
  
• Proficient in data integrity, CAPA management, change control, and deviation handling.
  
• Excellent communication, collaboration, and problem-solving abilities.
  
• Ability to train and guide cross-functional teams.