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Quality Control 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

📌 QC Head | General Manager (G7) | Company: [Name]

📍 Location: [Location]
💼 Company: [Company Name]
🕒 Experience: 20+ Years (Injectables + OSD with Regulatory Experience)

Role Overview

The QC Head is accountable for ensuring the supply of high-quality, GMP-compliant drug products. This role involves defining operational strategy for the Quality Control system, aligning quality control goals with Sun Pharma compliance, product quality management objectives, and regulatory requirements. The incumbent will lead the QC team to ensure timely release of products, optimize resources, and oversee investigations to minimize errors, ensuring full adherence to GMP norms.

Key Responsibilities

Regulatory Compliance & Quality Metrics: Ensure adherence to QC regulatory requirements, track quality metrics, and drive continuous improvement to reduce errors and enhance compliance.
QC Operations Management: Oversee the release of incoming materials, drug products, and stability studies as per cGMP and regulatory commitments.
Analytical Method Validation: Ensure analytical methods are validated and transferred as per regulatory requirements.
Continuous Improvement: Design and implement continuous improvement initiatives in QC operations to enhance efficiency, compliance, and cost-effectiveness.
Leadership & Team Development: Provide strong leadership to ensure QC objectives are met, while also coaching and developing direct and indirect reports through ongoing performance feedback and training.
Regulatory Inspections & Audits: Ensure site readiness for regulatory inspections and internal audits, addressing CAPAs promptly.
Budgeting & Resource Management: Develop and manage QC budgets, track expenditures, and ensure efficient use of resources for QC laboratory operations.
Collaboration & Synergy: Foster smooth collaboration with other Sun Pharma sites and leverage synergies for improved efficiency.

Job Scope

  • Internal Interactions: Collaborate with various internal teams across departments.
  • External Interactions: Engage with regulatory agencies, partners, and other external stakeholders.
  • Geographical Scope: [If applicable]
  • Financial Accountability: Manage QC-related budgets, ensuring cost-effective and compliant operations.

Required Qualifications & Skills

🎓 Education:

  • Science or Pharmacy Graduates (or equivalent).

💼 Experience:

  • 20+ years of experience in Quality Control, specifically in Injectables and OSD.
  • Strong background in managing regulatory compliance, particularly in USFDA-approved sites.

Desired Skills

  • Expertise in regulatory requirements for both Injectables and OSD.
  • Proven track record in analytical method validation, stability studies, and managing CAPA.
  • Leadership and team management skills, with experience in budgeting and resource allocation.

Work Conditions

  • Travel Estimate: [If applicable]
  • Full-time position based in [Location].

📩 Apply Now

 

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