Cleaning Validation Expert (Pharma QA)

0 years

0 Lacs

Posted:5 days ago| Platform: Linkedin logo

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On-site

Job Type

Full Time

Job Description

Company Description

Jaidev Pharma Placement specializes in providing exceptional human resources services to the pharmaceutical industry across India. With over two decades of experience in Pharmaceutical Sales and four years in Hiring, Recruitment, and Training, our agency stands as a reliable partner for top-notch talent acquisition. We focus on strategic planning, business analysis, and revenue generation to meet our clients' needs. Our agency is dedicated to helping organizations achieve success while fulfilling long-term career aspirations for employees.


Role Description

  1. Having good knowledge for the execution, documentation, and review of cleaning validation
  2. activities in compliance with cGMP, regulatory guidelines, and internal policies.
  3. Ensuring that equipment cleaning processes prevent cross-contamination and meet stringent
  4. regulatory standards.
  5. Plan, execute, and document cleaning validation and verification protocols (IQ, OQ, PQ).
  6. Coordinate with Production, Quality Control, and Engineering teams for sampling, testing, and
  7. equipment readiness.
  8. Develop and review cleaning validation protocols, reports, SOPs, and risk assessments.
  9. Perform swab and rinse sampling for cleaning validation and interpret analytical results in
  10. laboration with QC.
  11. Maintain validation master plans (VMP) and cleaning validation schedules.
  12. Investigate and troubleshoot cleaning failures and deviations; perform root cause analysis and
  13. implement corrective actions.
  14. Ensure compliance with current regulatory guidelines (FDA, EMA, WHO, etc.).
  15. Support internal and external audits related to cleaning validation.
  16. Maintain all validation documentation in an organized and compliant manner.
  17. Sound understanding of cleaning validation lifecycle, acceptance criteria, and residue limits.
  18. Familiarity with GMP regulations and international regulatory expectations.

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