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Qa Head

20+ years
₹60 – ₹85 LPA
1 June 28, 2025
Job Description
Job Type: Full Time Education: B.Pharm / M.Pharm 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

Location: Not Specified
Company: Not Specified
Role: QA Head

Qualification:

  • B.Pharm / M.Pharm

Experience:

  • Minimum 20+ years of experience in pharmaceutical Quality Assurance with leadership responsibilities

Job Summary:
The QA Head is responsible for overseeing all aspects of Quality Assurance at the site, including In-process QA, Analytical QA, QA Validation, Quality Management Systems, and Documentation. The role ensures strategic alignment with regulatory requirements and Sun Pharma’s product quality objectives. The QA Head will lead batch disposition, maintain regulatory compliance, manage QA resources, and ensure the site is audit-ready at all times.

Key Responsibilities:

  • Define and implement operational strategy and roadmap for Quality Assurance at the site.

  • Ensure compliance with product quality management objectives, Sun Pharma’s global QA strategy, and applicable regulatory standards.

  • Lead all QA activities across the site, ensuring smooth operations and efficient resource allocation.

  • Responsible for batch disposition and ensuring only compliant products are released to the market.

  • Provide leadership and technical expertise to meet business and functional QA goals.

  • Continuously improve QA systems and processes for enhanced compliance and performance.

  • Coach, mentor, and develop QA team members through feedback, performance reviews, and training programs.

  • Address and manage performance issues promptly and consistently.

  • Ensure sufficient staffing and capability to comply with GxP standards.

  • Maintain site readiness for regulatory and internal audits; ensure timely and effective implementation of CAPA.

  • Lead site Quality Management Reviews and drive continuous improvement across functions.

  • Investigate market complaints, product failures, and deviations with effective CAPA in line with defined timelines.

  • Guarantee compliance with product, process, and release-related regulatory requirements.

  • Implement and enforce quality-related SOPs, policies, and standards across QA operations.

  • Lead internal and external audit facilitation, ensuring findings are addressed site-wide.

  • Monitor industry trends and internal challenges to enhance QA systems and culture.

  • Authorize and control quality documents, including amendments and written procedures.

  • Ensure initial and ongoing training of QA personnel as per requirements.

  • Oversee validation and qualification activities per site procedures.

  • Effectively manage the Change Control and Quality Risk Management processes at the site.

  • Uphold corporate values of Pride, Accountability, Integrity, and Diligence in all QA activities.

Estimated Salary: ₹60 – ₹85 LPA (depending on site complexity, regulatory exposure, and team size)