Cleaning Validation Expert (Pharma QA)

4 - 8 years

0 Lacs

Posted:20 hours ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

As a part of Jaidev Pharma Placement, your role involves having a good knowledge for the execution, documentation, and review of cleaning validation activities in compliance with cGMP, regulatory guidelines, and internal policies. You will be responsible for ensuring that equipment cleaning processes prevent cross-contamination and meet stringent regulatory standards. Your responsibilities will include: - Planning, executing, and documenting cleaning validation and verification protocols (IQ, OQ, PQ). - Coordinating with Production, Quality Control, and Engineering teams for sampling, testing, and equipment readiness. - Developing and reviewing cleaning validation protocols, reports, SOPs, and risk assessments. - Performing swab and rinse sampling for cleaning validation and interpreting analytical results in collaboration with QC. - Maintaining validation master plans (VMP) and cleaning validation schedules. - Investigating and troubleshooting cleaning failures and deviations; performing root cause analysis and implementing corrective actions. - Ensuring compliance with current regulatory guidelines (FDA, EMA, WHO, etc.). - Supporting internal and external audits related to cleaning validation. - Maintaining all validation documentation in an organized and compliant manner. Additionally, you should have a sound understanding of the cleaning validation lifecycle, acceptance criteria, and residue limits. It is essential to be familiar with GMP regulations and international regulatory expectations. No additional details of the company were provided in the job description.,

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