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Cdymax India Pharma
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Officer - Quality Assurance (Qualification)

Officer - Quality Assurance (Qualification)

Cdymax India Pharma

10 - 12 years

6 - 8 Lacs

Bengaluru

Posted:1 month ago| Platform:

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Skills Required

Change Control Process Validation QMS Active Pharmaceutical Ingredient API Distribution Related Market Bulk Drugs Sop Preparation

Work Mode

Work from Office

Job Type

Full Time

Job Description

JOB RESPONSBILITIES ON QUALIFICATION OF EQUIPMENT, FACILITY & UTILITIES - QA RESPONSIBILITIES: Ensuring of preventive maintenance of all equipments carried out as per schedule. Review of calibration certificates. Review of all equipment and utilities qualification documents (URS,IQ,OQ and PQ). Review of requalification protocol and reports for all equipments as per schedule. Review of temperature mapping protocol and report as per the schedule. Preparation of product quality review as per SOP. Review of preventive maintenance and calibration schedules and checklist. Issuance, retrieval and archival of registers to respective departments. Line clearance for equipments, clean room area and repacking area during product-to-product change over. Review of Water analysis reports and Microbiology reports. Ensure Data integrity. Conducting trainings. Review and compliance of engineering department and conducting GMP walk through audit. Preparation and review of Standard Operating Procedures. Involving in investigations and review of Deviations and others QMS activities. Involving in Internal audits. Handling of document control system.

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Officer - Quality Assurance (Qualification)