Lead -QMS

ACG Universal Capsules Pvt. Ltd

1. Organization Context

Position Title:

1. Job Objective

• To define Quality of system
• To ensure QMS compliance as per regulatory requirements / Audit findings.

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.
• 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.

1. 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

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

1. Educational and Experience Requirements

Minimum RequirementDesiredLevel of Education

• Graduate
• Bachelors in pharmacy

Experience

• 5 Years
• 8 Years

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