Site Quality Head (OSD)

About Sun Pharma and Role Overview

At Sun Pharma, we nurture a growth-focused environment where you can steer your career and flourish within a collaborative community. As the Site Quality Head for OSD in Guwahati, Assam, you will be instrumental in assuring the production of superior, GMP-compliant products in line with regulatory standards and company policies. This role involves shaping the operational quality strategy and steering quality assurance and control activities at the site.

Key Responsibilities

• Evaluate and resolve quality concerns at the manufacturing site, ensuring adherence to QA/QC regulations and driving improvement in quality metrics alongside site operations management.
• Design, implement, and maintain compliance with all quality-related SOPs, policies, standards, and systems at the location.
• Champion initiatives for continuous improvement to boost compliance, efficiency, and cost savings across operations.
• Ensure sufficient resource allocation, including manpower, to meet GxP compliance requirements consistently.
• Promote the harmonization and consistent implementation of Quality Systems in accordance with Global Quality standards.
• Oversee investigations into market complaints, failures, and deviations, enforcing timely and effective corrective and preventive actions.
• Maintain perpetual readiness for regulatory inspections and internal audits, facilitating corrective actions for any noted findings.
• Stay attuned to industry trends and internal challenges to identify and apply enhancements to site quality management and processes.
• Guarantee conformity to regulatory mandates pertaining to product quality, processes, and release procedures.
• Manage the site quality budget including revenue, capital expenditures, and headcount planning to align with fiscal objectives.
• Ensure the release of safe, effective drug products compliant with cGMP and regulatory commitments.
• Collaborate effectively across all company sites and functions to leverage strategic synergies.
• Uphold compliance with EHS policies, laboratory SOPs, and GMP requirements.
• Lead the establishment, maintenance, and enforcement of Quality Management Systems (QMS) to meet regulatory and company standards.
• Direct internal audits, regulatory inspections, and customer audits, ensuring timely resolution of issues and sustained compliance readiness.
• Review and approve deviations, change controls, investigations, and CAPA activities to manage risk and resolve quality matters effectively.
• Develop and mentor the quality team while fostering a culture of quality through continuous improvement programs and quality metric monitoring.

Qualifications and Experience

• Educational Qualification: Bachelor’s or Master’s degree in Pharmacy (B.Pharm/M.Pharm).
• Experience: Over 20 years in related quality management roles within pharmaceutical manufacturing.

Additional Information

This role requires a seasoned professional capable of leading a site’s quality systems and regulatory compliance efforts rigorously and effectively. The job description outlines key responsibilities but does not encompass every duty, which may be adjusted to fit evolving company needs or incumbent capabilities.

Sun Pharma prioritizes employee success and well-being, offering comprehensive benefits to support growth and achievement in a dynamic workplace environment.