Website:
kaapro.co.in
Job details:
General Requirements:
• The ideal candidate should have exposure to equipment qualification, API plants, and
formulation plants.
• Support GMP manufacturing, laboratory, and utility systems through qualification lifecycle
activities including DQ, IQ, OQ, and PQ.
• Perform validation of manufacturing equipment, utilities (HVAC, water systems,
compressed air), and computerized systems.
• Ensure compliance with cGMP, FDA, MHRA, WHO, and other relevant regulatory
guidelines.
• Collaborate with cross-functional teams (Production, QA, QC, and Engineering) during
validation projects.
• Conduct risk assessments, gap analyses, and change control evaluations related to
validation.
• Maintain and periodically update Validation Master Plans (VMP).
• Troubleshoot validation-related issues and provide technical support to operations.
• Ensure timely completion of validation projects as per project timelines.
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