QA Coordinator

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