Quality Control Head
Position: GM (G7) / General Manager
Function: Global Quality & Compliance
Location: [Not specified]
Company: [Not specified]
No. of Direct Reports: [Not specified]
Job Summary: The Quality Control Head is accountable for ensuring the supply of high-quality, GMP-compliant drug products. The role includes defining the operational strategy for the quality control system at the site, finalizing quality control goals, objectives, and strategy in alignment with Sun Pharma compliance, product quality management objectives, and regulatory requirements. The incumbent will conduct effective team reviews, provide direction and guidance, and develop team competence to ensure product quality in adherence to GMP norms and timelines. This role requires individual compliance with regulatory requirements, GxP's, and applicable department programs, including training, documentation, SOPs, and Sun Pharma policies and procedures.
Areas of Responsibility:
Key Responsibilities:
Assess and ensure compliance with QC regulatory requirements and track quality metrics, working to drive them down.
Manage site Quality Control activities and resources, ensuring smooth QC operations, including the release of incoming materials, drug products, and facilitating stability studies of commercial products per cGMP requirements and regulatory commitments.
Ensure that analytical methods are validated/transferred at the site laboratory as per cGMP requirements and regulatory commitments.
Monitor and review investigations and QMS with adequate CAPA (Corrective and Preventive Actions) to minimize errors.
Design, implement, and review compliance-related SOPs, policies, standards, and quality systems with QC section heads.
Execute continuous improvement initiatives to enhance compliance, drive efficiencies, and cost-effectiveness.
Facilitate harmonization and consistent implementation of quality systems and procedures at the site in alignment with regional/global quality policies/standards.
Ensure the site’s readiness for regulatory agency inspections and internal audits, and manage the implementation of corrective actions for any observations made.
Manage resources for the QC laboratory to achieve desired productivity and SLAs defined by KPIs, continually improving process excellence.
Provide leadership and expertise to ensure achievement of all Quality Control objectives at the site.
Coach and develop direct and indirect reports through ongoing performance feedback, annual performance reviews, and the provision of training and development opportunities.
Manage performance issues consistently and in a timely manner.
Develop site quality control revenue, capital budgets, and headcount projections; track and manage expenditures and headcount to budget over the fiscal year.
Ensure compliance with regulatory requirements for product, process, and release procedures.
Ensure smooth collaboration with all Sun Pharma sites and leverage synergies.
Job Scope:
Internal Interactions: [Not specified]
External Interactions: [Not specified]
Geographical Scope: [Not specified]
Financial Accountability: [Not specified]
Job Requirements:
Educational Qualification:
Science or Pharmacy Graduates or Equivalent
Specific Certification:
[Not specified]
Skills:
Injectables & OSD (Oral Solid Dosage)
USFDA regulations
Experience:
20+ years of experience in OSD and Injectables with regulatory experience.
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