Supervisor

3 weeks ago


Pithampur, India ACG Worldwide Full time

**Date**:Jun 4, 2024

**Location**: Pithampur, India

**Company**:ACG
- Group Company- ACG Capsules Pvt Ltd- Primary Responsibilities- To ensure the Plant complies to the QMS system as per the laid down guidelines.
- Functional
- Core- 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.
- Destruction of documents after its expiry period with proper record.
- Ensure all the Quality Assurance documents are filled completely.
- To ensure effective implementation of DMS system in all departments.
- Support to QA Manager during the internal and external audits.
- Support to QA manager by carry out self-inspection / CTQ audits
- To carry out inspection of Transit vehicle.
- Working with the Engineering Team / Calibration team with compliance with GEFU
- Handling of DMS system.
- 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 Management associate on Good Documentation Practices (GDP)
- Training Plant associates on Good Documentation Practices (GDP)
- Training on compliance to Data Integrity.
- Training on the requirement of Online documentation.
- Key Result Areas- Strengthening the review mechanism of batch records
- Effective review of batch records.
- Timely release batches as per the daily plan.
- Timely updating QMS documents to keep all in line with regulatory requirements
- Compliance during Internal, external & Regulatory audits
- Improve document control across plant
- To ensure training of all associates on QMS
- Key Interfaces- Qualification - Masters /bachelor’s in science /Pharmacy/Assurance/Analytical Chemistry
- Experience - 0 to 3 yr.
- Competencies


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