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Section Head - Qms & Compliance

12-16 years
Not Disclosed
10 Nov. 28, 2024
Job Description
Job Type: Full Time Education: B. Pharma/M. Pharma Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Division: Quality

Department: Corporate Quality Assurance
Sub-Department: Third Party Quality

Employment Type: Full-time


Job Purpose

Ensure that products manufactured by contract manufacturing units meet quality standards, ensure patient safety, and comply with regulatory requirements before market release.

Oversee the review, approval, and implementation of change control, deviations, batch failures, recalls, CAPA (Corrective and Preventive Actions), and market complaints to consistently deliver quality products.

Validate that all master documents provided to contract manufacturing units include the necessary instructions to monitor manufacturing activities and produce compliant, high-quality products.


Key Accountabilities

  1. Deviation and CAPA Management:

    • Ensure deviations, OOS (Out of Specification), OOT (Out of Trend), market complaints, and CAPAs are closed effectively before batch release, ensuring no impact on product quality.
    • Review and approve deviations in coordination with operational QA teams, technical teams, and unit QA heads, ensuring thorough investigation and implementation of CAPAs.
  2. Global CAPA Review:

    • Evaluate and approve Global CAPAs to prevent recurring non-conformance in contract manufacturing units.
  3. Batch Failure Investigation:

    • Initiate and track batch failure investigations and CAPA implementation to decide on batch rejection or reprocessing, aligning with regulatory standards.
  4. Change Control:

    • Review and approve change requests to assess their impact, ensuring compliance with product quality, regulatory, and customer requirements.
  5. Recall Management:

    • Lead recall activities to withdraw defective products from the market, minimizing patient health risks and ensuring regulatory compliance.
  6. Master Document Review:

    • Approve master batch documents to ensure they include complete instructions for producing compliant, high-quality products that meet customer and regulatory requirements.

Education Qualification:

  • B. Pharma or M. Pharma

Experience Required:

  • 12–16 years of experience in Quality Assurance within the pharmaceutical industry.

Job Location:

  • Vikhroli

Competencies and Skills:

  1. Core Competencies:

    • Collaborate to Succeed
    • Innovate to Excel
    • Perform with Accountability
    • Lead with Empathy
    • Act with Agility
  2. Technical and Leadership Skills:

    • Strong domain knowledge in pharmaceutical quality assurance.
    • Effective people management and leadership abilities.