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Open nowPosted 15 days ago

Executive, QA Validation

Amneal India91 open roles

Where
Ahmedabad City, Gujarat, India
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Your applicationOpen nowExecutive, QA ValidationAmneal India · Ahmedabad City, Gujarat, India

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  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

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The clock on this job

Early applications get read.

13.5% of postings close within 7 days. Measured by our own scanner across the market. Amneal India postings stay open a median of 6 days.

Share of postings closed within
  1. 2.3%1 day
  2. 4.6%3 days
  3. 13.5%7 days
  4. 21.8%14 days
  5. 36.6%30 days
  6. 58.9%60 days
This job: posted 15 days ago

Amneal India median: 6 days open

The posting

Job Description

Description:

  • Prepare and review qualification protocols and reports for equipment, utilities, and systems (DQ, IQ, OQ, PQ, as applicable).
  • Coordinate and monitor qualification activities with Engineering, Production, and Validation teams.
  • Ensure qualification documentation complies with GMP and regulatory requirements. Maintain qualification schedules and ensure periodic requalification is completed on time.
  • Conduct quality risk assessments using tools such as FMEA, HACCP, or risk matrices.
  • Identify potential quality risks and recommend appropriate mitigation strategies.
  • Ensure risk management documentation is maintained and periodically reviewed.
  • Draft, review, revise, and maintain Standard Operating Procedures (SOPs), work instructions, protocols, and quality documents.
  • Ensure document control procedures are followed throughout the document lifecycle.
  • Coordinate periodic review of controlled documents.
  • Provide training on new or revised SOPs and maintain training records.
  • Identify opportunities for process improvement and quality enhancement.
  • Support implementation of quality metrics and trend analysis.
  • Participate in cross-functional quality improvement projects.
  • Develop and review process validation protocols, reports, and validation master plans.
  • Coordinate execution of process validation activities with cross-functional teams.
  • Evaluate validation data and ensure processes consistently meet predefined acceptance criteria.
  • Support cleaning validation, analytical method validation, and computerized system validation where applicable.

Additional Skills :

  • Knowledge of GAMP 5 and 21 CFR Part 11.
  • Strong Understanding of ALCOA+ principles.
  • Performing risk assessments using tools like FMEA, HACCP, and risk matrices.
  • Hands-on experience with IQ, OQ, PQ, and requalification of manufacturing and laboratory equipment.
  • Strong Project Management Skills

Qualifications

Education:

  • B. Pharm B. Pharm - Required
  • M. Pharm M. Pharm - Preferred

Experience:

  • 2 years or more in 2 - 5 Years

Specialized Knowledge: Licenses:

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