07 Oct
|
AK GROUP
|
Roorkee
Plan, execute, and review cleaning validation protocols and reports for manufacturing equipment and production areas.
Prepare and review Cleaning Validation Protocols (CVP), sampling plans, and acceptance criteria.
Perform swab and rinse sampling as per approved procedures.
Coordinate with Production, QC, and Microbiology teams during cleaning validation activities.
Ensure validation of cleaning procedures for product-to-product and campaign changeovers.
Review analytical results for API/product residue, cleaning agents, and microbial limits.
Ensure compliance with GMP, SOPs, and regulatory requirements.
Conduct MACO (Maximum Allowable Carryover) calculations and verify acceptance limits.
Investigate deviations, failures,
and out-of-limit results related to cleaning validation.
Prepare and review risk assessments, validation reports, and supporting documentation.
Monitor periodic review/revalidation of cleaning processes.
Maintain complete and accurate QA documentation and validation records.
Support regulatory and customer audits related to cleaning validation.
Ensure implementation of CAPA arising from cleaning validation observations or failures.
Pay: ₹40,000.00 - ₹50,000.00 per month
Work Location: In person
📌 Qa Cleaning Validation Injectable Background Roorkee
🏢 AK GROUP
📍 Roorkee