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Site Quality Head

20+ years
Not Disclosed
10 Jan. 31, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

📌 Site Quality Head | Sun Pharma | Location: [Insert Location]

📍 Location: [Location]
💼 Company: Sun Pharmaceutical Industries Ltd
🕒 Experience: 20+ years in pharmaceutical quality management leadership roles

Position Summary

The Site Quality Head is responsible for ensuring the supply of high-quality, GMP-compliant products at the site. This role involves defining and implementing operational strategies for quality system management while aligning quality assurance and control goals with Sun Pharma compliance and regulatory requirements. The incumbent will lead the site’s QA, QC, and Stability teams, proactively addressing quality issues and ensuring readiness for regulatory inspections and internal audits.

Key Responsibilities

Quality Assurance & Control Compliance: Ensure compliance with QA/QC regulatory requirements in manufacturing operations, track and reduce quality metrics in collaboration with site management.
SOPs & Policies: Design, implement, and ensure compliance with all quality-related SOPs, policies, and quality systems at the site.
Continuous Improvement: Develop and execute continuous improvement initiatives to enhance compliance, efficiency, and cost-effectiveness at the site.
Resource Management: Ensure availability of adequate resources, including manpower, to maintain compliance with GxP requirements.
Regulatory Inspections & Audits: Ensure readiness for regulatory inspections and internal audits, implementing corrective actions based on feedback from agencies or internal teams.
Market Complaints & Deviations: Investigate market complaints and deviations, ensuring corrective and preventive actions are implemented in line with timelines.
Industry Trends: Monitor industry trends to identify opportunities for improving site quality management and processes.
Collaboration & Synergy: Ensure smooth collaboration with all Sun Pharma sites and functions, leveraging synergies for better operational performance.
Budgeting & Financial Oversight: Develop site quality revenue, capital budgets, and headcount projections, managing expenditures and headcount as per budget.
Product Release: Ensure the release of safe and effective drug products from the site, adhering to cGMP and regulatory commitments.
Compliance: Follow the EHS policy and GMP requirements, maintaining consistent compliance with laboratory SOPs.

Job Requirements

🎓 Education:

  • Science or Pharmacy Graduates (or equivalent).

💼 Experience:

  • 20+ years in pharmaceutical quality management leadership roles, with significant experience in a similar role currently.

Desired Skills

  • Expertise in quality management systems, regulatory requirements, and continuous improvement.
  • Strong leadership and team management skills.
  • Proven experience in ensuring compliance with GxP standards and effective resource management.

Work Conditions

  • Full-time position
  • Location: [Insert location]

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