Lead -QMS

ACG

3 - 5 years

4 - 5 Lacs

aurangabad west bengal india

Posted:1 day ago| Platform: Foundit logo

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Skills Required

qms qms compliance quality system management internal quality auditor qms implementation

Work Mode

On-site

Job Type

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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