Location: Not Specified
Job Title: Quality Control Head
Job Grade: GM (G7) / General Manager
Function: Global Quality & Compliance
Sub-function: Not Specified
Number of Direct Reports: Not Specified
Qualification:
Graduate in Science or Pharmacy (or equivalent)
Experience:
20+ years of experience in Quality Control, with exposure to OSD and Injectable dosage forms
Hands-on experience in regulatory environments including USFDA compliance
Job Summary:
The QC Head is responsible for ensuring the supply of high-quality, GMP-compliant drug products by defining and leading the operational strategy of the site’s Quality Control (QC) function. The role involves aligning QC goals with Sun Pharma's compliance objectives, product quality expectations, and regulatory requirements. The QC Head will manage resources, lead the team, implement continuous improvement initiatives, and ensure all products released from the site meet strict quality standards and timelines.
The incumbent must also ensure personal and departmental compliance with all applicable GxP regulations, training requirements, documentation systems, SOPs, and Sun Pharma’s policies.
Key Responsibilities:
Assess and ensure site QC compliance with regulatory requirements; track and reduce quality metrics deviations.
Oversee all QC activities, including release of incoming materials, finished drug products, and stability studies per cGMP.
Ensure timely validation and/or transfer of analytical methods at site laboratories in line with regulatory commitments.
Monitor investigations and quality management systems with effective CAPA to prevent recurrences.
Lead the design, implementation, and periodic review of SOPs, policies, and quality systems across QC functions.
Drive continuous improvement initiatives to enhance compliance, operational efficiency, and cost-effectiveness.
Harmonize and standardize quality systems in alignment with regional/global policies.
Maintain inspection readiness for regulatory agencies and internal audits; ensure corrective actions are appropriately executed.
Ensure the provision of adequate QC laboratory resources to meet productivity goals and KPIs.
Provide strategic leadership, coaching, and development to the QC team to build a competent, high-performance workforce.
Conduct regular performance reviews, training programs, and manage underperformance where applicable.
Prepare and manage quality control budgets and headcount forecasts; track and control expenditures.
Ensure compliance with all regulatory requirements regarding product, process, and release procedures.
Foster collaboration across Sun Pharma sites to promote standardization and synergy.
Additional Responsibilities:
Perform other responsibilities as assigned by leadership.
May involve travel as per business requirements.
Estimated Salary: ₹60 – ₹90 LPA (depending on experience, plant size, and regulatory scope)
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