Urgently Hiring for API QA - (Roles - QMS, IPQA, Analytical Assurance, Documentation & Training Sections)
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Handling of QMS activities like Conducting Investigations, Change Controls, deviations and related documents.
Review Batch Manufacturing and Analysis records.
Awareness about Data integrity principles and experience in handling Data Integrity related issues.
Handling of Regulatory inspections & customer audits.
Control of process validation and cleaning validation activities. Review validation protocols, reports. Knowledge of water system & computer system validation.
Maintain qualifications records. Ensure proper label control. Lay down procedures for periodic calibrations of various instruments.
Prepare Annual Product review Report, OOS and Deviations trending.
Take rounds in production, QC and stores department to ensure compliance.
Manage Training for entire site. Provide documents required to RA. Maintain SOP's.
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