Site Quality Head (OSD)

Sun Pharmaceutical Industries, Inc.; Kamrup Metropolitan; On-site; INR 1,800,000 - 2,800,000; Full time

Job summary

Sun Pharma India seeks a Site Quality leader to oversee QA, QC and Stability at the site, defining quality strategy and ensuring compliance with GMP and regulatory requirements.

You will drive continuous improvement, lead internal audits and inspections, develop the site quality team, and coordinate with global quality policies to release safe drug products.

Qualifications

• B.Pharm or M.Pharm degree required.

Responsibilities

• Assess quality issues at site and ensure compliance to QA/QC regulatory requirements in manufacturing operations at site and track quality metrics with site manufacturing management and drive them down.
• Accountable for designing/implementing and ensuring compliance to all quality related SOPs, Policies, Standards and Quality systems at the site.
• Design and execute continuous improvement initiatives at the site to enhance compliance, drive efficiencies and cost effectiveness.
• Responsible for ensuring availability of adequate resources, including manpower to maintain compliance with GXP requirements.
• Facilitate harmonization and consistent implementation of Quality Systems and procedures at site, in alignment with Global Quality policies/standards.
• Ensure market complaints, failures, deviations are investigated and corrective and preventive actions are implemented with adherence to timelines.
• Assure all time readiness of site for regulatory agency inspections/internal audits and appropriate implementation of corrective actions regarding observations made by the agencies/internal audit teams.
• Monitor industry trends/issues faced internally and identify scope for improving Site quality management and processes.
• Ensure compliance to regulatory requirements on product, process and release procedures.
• Prepare site quality revenue and capital budgets and headcount projections, track and manage expenditures and headcount to budget over the fiscal year.
• Ensure release of safe and effective drug products from site as per cGMP requirement and regulatory commitment.
• Responsible for ensuring smooth collaboration with all Sun Pharma sites and functions to leverage synergies.
• Follow the EHS policy, laboratory standard operating procedures and maintain the compliance to GMP requirements
• Quality Management System (QMS) Leadership: Establish, implement, and maintain site quality systems in compliance with GMP, regulatory requirements, and company standards.
• Product Quality & Compliance Oversight: Ensure all manufacturing, packaging, testing, and distribution activities meet approved quality specifications and regulatory expectations.
• Audit & Inspection Management: Lead internal audits, regulatory inspections, and customer audits, ensuring timely closure of observations and continuous compliance readiness.
• Deviation, CAPA & Risk Management: Review and approve deviations, change controls, investigations, and Corrective & Preventive Actions (CAPA) to ensure effective resolution of quality issues.
• Team Development & Continuous Improvement: Lead and develop the site quality team, drive quality culture initiatives, monitor quality metrics, and implement continuous improvement programs to enhance product quality and operational excellence.

Education

B.Pharm / M.Pharm

Job description

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At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

Job summary :

Ensure the supply of high quality, GMP compliant products, define operational strategy for quality system management at site, finalize site quality assurance and quality control goals, objectives and strategies in line with Sun Pharma compliance, product quality management objectives and regulatory requirements.

Provide leadership and direction to ensure achievement of all site accountabilities for QA, QC and Stability at site. Proactively assess quality issues at site and ensure compliance to QA/QC regulatory requirements in manufacturing operations at the site and track quality assurance/control metrics with site manufacturing and drive them down. Assure all time readiness of site for regulatory agency inspections\internal audits at any given point

The incumbent will assure individual compliance with the all concerned regulatory requirements, GxP’s and applicable department programs, including training, documentation, Standard Operating Procedures, and Sun Pharma Global Quality Policies, Standards and Procedures

Key responsibilities:

• Assess quality issues at site and ensure compliance to QA/QC regulatory requirements in manufacturing operations at site and track quality metrics with site manufacturing management and drive them down.
• Accountable for designing/implementing and ensuring compliance to all quality related SOPs, Policies, Standards and Quality systems at the site.
• Design and execute continuous improvement initiatives at the site to enhance compliance, drive efficiencies and cost effectiveness.
• Responsible for ensuring availability of adequate resources, including manpower to maintain compliance with GXP requirements.
• Facilitate harmonization and consistent implementation of Quality Systems and procedures at site, in alignment with Global Quality policies\standards.
• Ensure market complaints, failures, deviations are investigated and corrective and preventive actions are implemented with adherence to timelines.
• Assure all time readiness of site for regulatory agency inspections\internal audits and appropriate implementation of corrective actions regarding observations made by the agencies\internal audit teams.
• Monitor industry trends/issues faced internally and identify scope for improving Site quality management and processes.
• Ensure compliance to regulatory requirements on product, process and release procedures.
• Prepare site quality revenue and capital budgets and headcount projections, track and manage expenditures and headcount to budget over the fiscal year.
• Ensure release of safe and effective drug products from site as per cGMP requirement and regulatory commitment.
• Responsible for ensuring smooth collaboration with all Sun Pharma sites and functions to leverage synergies.
• Follow the EHS policy, laboratory standard operating procedures and maintain the compliance to GMP requirements
• Quality Management System (QMS) Leadership: Establish, implement, and maintain site quality systems in compliance with GMP, regulatory requirements, and company standards.
• Product Quality & Compliance Oversight: Ensure all manufacturing, packaging, testing, and distribution activities meet approved quality specifications and regulatory expectations.
• Audit & Inspection Management: Lead internal audits, regulatory inspections, and customer audits, ensuring timely closure of observations and continuous compliance readiness.
• Deviation, CAPA & Risk Management: Review and approve deviations, change controls, investigations, and Corrective & Preventive Actions (CAPA) to ensure effective resolution of quality issues.
• Team Development & Continuous Improvement: Lead and develop the site quality team, drive quality culture initiatives, monitor quality metrics, and implement continuous improvement programs to enhance product quality and operational excellence.

Job Requirements

Educational Qualification

B.Pharm / M.Pharm

Experience

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

Disclaimer:

The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).