Executive/Sr Executive- QA

3 weeks ago

Pithampur, India Gufic Group Full time

  • Process Validation:

  • Plan and execute process validation activities for sterile injectable products as per cGMP and regulatory expectations.

  • Prepare and review validation protocols and reports, ensuring compliance with internal SOPs and global regulatory guidelines (e.g., USFDA, EU-GMP, WHO).

  • Cleaning Validation:

  • Develop and implement cleaning validation strategies for critical manufacturing equipment and facilities.

  • Review of cleaning validation protocols, analytical methods, and result interpretation to ensure carry-over limits are within acceptable criteria.

  • Hold Time Study:

  • Coordinate and conduct hold time studies for intermediates, bulk, and in-process materials to establish scientifically justified limits.

  • Review and trend hold-time data, identifying areas requiring optimization or revalidation.

  • Annual Product Quality Review (APQR):

  • Compile and review data for APQRs across product portfolios, analyze trends, and identify areas for continuous improvement.

  • Liaise with cross-functional teams (QA, QC, Production) to gather and verify relevant documentation and data.

  • New Product Introduction - Risk Assessment:

  • Lead quality risk assessment activities for new injectable products, including impact analysis on facility, equipment, personnel, and processes.
  • Participate in tech transfer meetings and review of validation and qualification documentation related to NPIs.
  • Review and trend hold-time data, identifying areas requiring optimization or revalidation.

  • Annual Product Quality Review (APQR):

  • Compile and review data for APQRs across product portfolios, analyze trends, and identify areas for continuous improvement.

  • Liaise with cross-functional teams (QA, QC, Production) to gather and verify relevant documentation and data.

  • New Product Introduction Risk Assessment:

  • Lead quality risk assessment activities for new injectable products, including impact analysis on facility, equipment, personnel, and processes.
  • Participate in tech transfer meetings and review of validation and qualification documentation related to NPIs.

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