Quality Assurance Supervisor

2 weeks ago


india ACG World Full time

Job Objective:

To assure Quality of products

To ensure QMS compliance as per regulatory requirements / Audit findings

Ontime BMR release with 100% compliance


Primary responsibilities:

Strategic and planning

Functional

Core:-

  • review of production schedule and their compliance to the specific requirements in the manufacturing of products.
  • correct and timely issuance of batch documents.
  • the completed batch documents and ensure compliance to the manufacturing process before the batch is released.
  • timely review and release of batch manufacturing record as per GDP.
  • traceability and reconciliation of All documents and review the same for non-compliance.
  • proper storage of all the Batch manufacturing record in a systematic manner for easy and quick retrieval.
  • of documents after its expiry period with proper record.
  • all the Quality Assurance documents are filled completely.
  • ensure effective implementation of DMS system in all departments.
  • to QA Manager during the internal and external audits.
  • to QA manager by carry out self-inspection / CTQ audits
  • with the Engineering Team / Calibration team with compliance with GEFU
  • of DMS system.
  • of QMS system.


Internal process

  • to Regulatory Compliance,
  • to GMP Audit/Process Audit,
  • review and Batch Release to meet regulatory requirements,
  • c-GMP compliance during the entire manufacturing process.


People development

  • Management associate on Good Documentation Practices (GDP)
  • Plant associates on Good Documentation Practices (GDP)
  • on compliance to Data Integrity.
  • Training on the requirement of Online documentation.

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