QA Coordinator

1 - 2 years

0 - 2 Lacs

Posted:12 hours ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

Quality Assurance Batch Release

  1. Organization Context

Position Title:

  1. Job Objective

  • To assure Quality of products
  • Ontime BMR review and release with 100 % compliance.

  1. Primary responsibilities

Strategic and planning

  • To ensure the Plant complies to the QMS system as per the laid down guidelines.

Functional

  • Review of production schedule and their compliance to the specific requirements in the manufacturing of products.
  • Ensure correct and timely issuance of batch documents.
  • Review the completed batch documents and ensure compliance to the manufacturing process before the batch is released.
  • Ensure timely review and release of batch manufacturing record as per GDP.
  • Ensure traceability and reconciliation of All documents and review the same for non-compliance.
  • Ensure proper storage of all the Batch manufacturing record in a systematic manner for easy and quick retrieval.
  • Maintenance and Destruction of documents after its expiry period with proper record as per SOP.
  • Support to QA Manager during the internal and external audits.
  • To perform Usage Decision of batch in absence of QA head.

Internal process

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

People development

  • Training on compliance to Data Integrity.
  • Training on the requirement of Online documentation.
  1. Key Result Areas

  • Strengthening the review mechanism of batch records
  • Effective review of batch records.
  • Timely release batches as per the daily plan
  • Compliance during Internal, external & Regulatory audits

  1. Key Interfaces

Internal InterfacesExternal Interfaces

  • All plant level functions
  • Sales & CSR
  • Marketing
  • Regulatory dept
  • Central Quality Assurance

  • Vendors, regulatory bodies, customer auditors
  1. Competency

Technical Competency T CompassLeadership Competency L CompassCompetencyLevelCompetency

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