Lead -QMS

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.