Executive/Sr Executive- QA

1 day 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.


  • Pithampur, Madhya Pradesh, India Gufic Group Full time ₹ 1,04,000 - ₹ 1,30,878 per year

    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...


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