Lead -QMS
8 hours ago
ACG Universal Capsules Pvt. Ltd.Job DescriptionFormat No.: 3500-HR-FORM
Quality Assurance - Documentation
- Organization Context
Position Title:QA Documentation (QMS)Employee Name: Grade:M10Department:Quality AssuranceLocation:Aurangabad Date of Joining: Associate Id: Reports to:Quality Assurance HeadReported by:Officer
Job Objective
To define Quality of system
To ensure QMS compliance as per regulatory requirements / Audit findings.
Primary responsibilities
Strategic and planning
- 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.
- Ensure traceability and reconciliation of All documents and review the same for non-compliance.
- Destruction of documents after its expiry period with proper record.
- Ensure all the Quality Assurance documents are filled completely.
- To ensure effective implementation of SIMPLOUD system in all departments.
- Support to QA Manager during the internal and external audits.
- Support to QA manager by carry out self-inspection
- Working with the Engineering Team / Calibration team with compliance
- Handling of SIMPLOUD system.
- To perform customer complaints handling as per procedure.
- Monitoring of CAPA.
- Maintaining, preparing & review of monthly QMS reports.
- Batch release in absence of the person responsible for batch release.
- Mr. Aniruddha Joshi is responsible for the documentation in absence of Ms. Mamta Deshmukh
Internal process
- Adherence to Regulatory Compliance,
- Compliance to GMP Audit/Process Audit,
- 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
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
Internal InterfacesExternal Interfaces
- All plant level functions
- Sales & CSR
- Marketing
- Regulatory dept
- Central Quality Assurance
Vendors, regulatory bodies, customer auditors
Competency
Technical Competency T CompassLeadership Competency L CompassCompetencyLevelCompetencyLevelTechnical knowledge AdvancedTechnical knowledge AdvancedQuality & Regulatory requirementsAdvancedQuality & Regulatory requirementsAdvancedProduction planning & controlAdvancedProduction planning & controlAdvancedCompliance & EHSAdvancedCompliance & EHSAdvancedCost ManagementAdvancedCost ManagementAdvanced Strategic Thinking Advanced
- Educational and Experience Requirements
Minimum RequirementDesiredLevel of Education
- Graduate
- Bachelors in pharmacy
Experience
- 5 Years
- 8 Years
Prepared By Date SignatureReviewed By Date Signature
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