Lead -QMS

17 hours ago

Aurangabad, Maharashtra, India ACG Full time ₹ 4,00,000 - ₹ 12,00,000 per year

ACG Universal Capsules Pvt. Ltd.Job DescriptionFormat No.: 3500-HR-FORM

Quality Assurance - Documentation

  1. 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

  1. Job Objective

  2. To define Quality of system

  3. To ensure QMS compliance as per regulatory requirements / Audit findings.

  4. 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

  1. 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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