Manager QA Validation

1 week ago

Indore, Madhya Pradesh, India Hector And Streak Consulting Full time ₹ 15,00,000 - ₹ 25,00,000 per year

Job Title: Section Head QA- Validation

Location: Indore

Industry: Pharmaceuticals / Healthcare

Functional Area: Quality Assurance / Validation

Employment Type: Full Time, Permanent

Experience Required: 15-20 Years. 3+ years in people management.

Job Summary

To lead and execute validation activities ensuring compliance with regulatory standards, robust documentation, and effective cross-functional collaboration. The role demands expertise in MACO calculations, sampling techniques, and QMS integration to uphold product safety and operational excellence.

Key Responsibilities

  • Prepare and execute validation protocols and reports in compliance with cGMP.
  • Perform MACO calculations for multi-product manufacturing setups.
  • Conduct swab and rinse sampling as per regulatory standards.
  • Lead hold time studies and ensure timely documentation.
  • Review and update QMS documents related to cleaning and process validation.
  • Support internal audits and regulatory inspections with validation evidence.
  • Collaborate with production, QA, and engineering teams for seamless validation execution.

Education Qualification

  • B. Pharma / M.Sc. in Chemistry, Microbiology, or related discipline.

Required Skills & Competencies

  • In-depth knowledge of cleaning validation lifecycle, MACO, sampling techniques, and QMS.
  • Strong understanding of regulatory guidelines (USFDA, EU, WHO, etc.).
  • Excellent documentation and analytical skills.
  • Effective communication and presentation abilities.
  • Proficiency in MS Office and validation software tools

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