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