Deputy Manager-Corporate Quality Assurance

2 weeks ago

Hyderabad Patancheru Sangareddy, India MSN Group Full time ₹ 12,00,000 - ₹ 36,00,000 per year

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.

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