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Piramal Pharma Ltd

Senior Executive-QA

Piramal Pharma Ltd India

Pharmaceutical Manufacturing · 1,001-5,000 employees

4 d ago
qa Mid (2-5 yrs) Full-time India
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About the role

The Senior Executive-QA will plan, execute, and monitor the Cleaning Validation Program for manufacturing equipment to ensure compliance with GMP and Data Integrity standards. Responsibilities include preparing validation protocols, conducting risk assessments, and overseeing sampling activities in coordination with the Quality Control laboratory.

What they look for

Cleaning Validation GMP Compliance Risk Assessment FMEA DIRA HACCP Swab Sampling Rinse Sampling PDE/HBEL Calculations MACO Determination Data Integrity ALCOA+ USFDA Guidelines EU GMP Annex 15 Statistical Evaluation Trend Analysis

Requirements

Candidates must have 3-5 years of relevant work experience in quality assurance and cleaning validation within a pharmaceutical environment. Proficiency in regulatory guidelines such as USFDA, EU GMP, and risk assessment tools like FMEA and HACCP is required.

Full description

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Division

Piramal Pharma SolutionsPiramal Pharma Solutions is a contract development and manufacturing  organization (CDMO), offering end-to-end development and manufacturing  solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.  

This enables us to offer a comprehensive range of services including Drug Discovery  Solutions, Process & Pharmaceutical Development services, Clinical Trial  Supplies, Commercial supply of APIs and Finished dosage forms. We also offer  specialized services like development and manufacture of Highly Potent APIs  and Antibody Drug Conjugation.  

Our capability as an integrated service provider  & experience with various technologies enables us to serve Innovator and  Generic companies worldwide.  

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Senior Executive-QAJob Description

To plan, execute, monitor, and maintain the Cleaning Validation Program for manufacturing equipment, ensuring compliance with current GMP requirements, regulatory expectations, company procedures, and Data Integrity principles.

Required Work Experience: 3-5 Years• Prepare and review Cleaning Validation Master Plans, protocols, reports, and risk assessments.

  • Support lifecycle management of cleaning processes through periodic verification.
  • Prepare and execute validation studies including initial qualification, revalidation, and cleaning verification.
  • Perform the Risk Assessment should evaluate potential product-to-product and product-to-cleaning agent carryover risks.
  • Plan and oversee swab and rinse sampling activities.
  • Ensure sampling is performed as per approved procedures and protocols.
  • Verify sampling locations and recovery study applicability.
  • Coordinate sample submission and testing with the Quality Control laboratory.

Technical Competencies

  • Cleaning Validation lifecycle approach.
  • Swab and rinse sampling techniques.
  • PDE/HBEL calculations and MACO determination.
  • Risk assessment tools (FMEA, DIRA, HACCP).
  • Validation documentation and GMP requirements.
  • Statistical evaluation and trend analysis.
  • Data Integrity principles (ALCOA+).
  • Knowledge of regulatory guidelines including USFDA, EU GMP Annex 15, PIC/S, and Schedule M.

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