Lead -QMS

1 week ago


Aurangabad, India ACG Full time

Job Description Responsibilities Strategic & Planning: - Ensure plant compliance with QMS as per defined guidelines. Functional / Core: - Review production schedules and verify compliance with product-specific requirements. - Ensure timely and correct issuance of batch documents. - Maintain traceability and reconciliation of all documents; review for non-compliance. - Handle destruction of expired documents with proper record-keeping. - Ensure all QA documents are fully completed. - Implement the SIMPLOUD system effectively across departments. - Support QA Manager during internal and external audits. - Carry out self-inspections as per QA Manager's guidance. - Collaborate with Engineering and Calibration teams for compliance. - Handle customer complaints as per procedure. - Monitor CAPA (Corrective and Preventive Actions). - Maintain, prepare, and review monthly QMS reports. - Perform batch release in the absence of the responsible person. - Ensure continuity of documentation management in absence of key personnel. Internal Processes: - Ensure adherence to regulatory compliance. - Maintain cGMP compliance throughout manufacturing. - Comply with GMP and process audits. People Development: - Train management and plant associates on Good Documentation Practices (GDP). - Provide training on compliance with data integrity and online documentation requirements.



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