Manager -Manufacturing QA

Role Summary:

Manufacturing QA Personnel

Key Responsibilities:

• Ensure

  cGMP compliance on the shop floor

  during all stages of sterile manufacturing (formulation, filtration, filling, lyophilization, sealing, and visual inspection).
• Conduct and supervise

  line clearance, in-process checks, and aseptic practices

  adherence.
• Monitor and record activities for

  Dry Powder, Liquid, and Lyophilized Injectable

  production lines.
• Perform

  real-time batch record review

  and initiate necessary corrections.
• Ensure

  cleanroom behavior compliance

  , including gowning validation, personnel movement monitoring, and hygiene compliance.
• Coordinate with Production, QC, and Engineering for

  investigation of deviations, change controls, and CAPAs

  related to the manufacturing process.
• Participate in the qualification/validation activities including

  media fills, equipment qualification, and cleaning validation

  .
• Review

  SOPs, protocols, and BMRs

  for compliance with regulatory standards and internal policies.
• Provide

  training and on-floor guidance

  to production teams regarding

  QA best practices

  and compliance expectations.
• Ensure readiness for audits and inspections by maintaining appropriate documentation and control practices.
• Collaborate with cross-functional teams for

  continuous improvement and risk mitigation

  in manufacturing QA processes.

Required Skills and Competencies:

• Strong understanding of

  sterile injectable manufacturing

  processes and controls, especially for

  SVP, Dry Powder, and Lyophilized

  dosage forms.
• Hands-on knowledge of

  cleanroom classifications, aseptic techniques, environmental monitoring

  , and

  equipment sterilization/cleaning

  .
• In-depth knowledge of

  cGMP, WHO, EU GMP, and PICS regulations

  .
• Experience handling

  deviations, OOS, CAPA, change controls, and batch record reviews

  .
• Ability to

  work in cross-functional teams

  and provide

  real-time QA support

  to operations.
• Proficiency in

  documentation practices

  and

  QA audits/inspections

  .
• Good communication, observation, and leadership skills.