Title:  QC Head

Title:

Quality Control Head

Business Unit:

Quality

Job Grade

DGM

Location:

Dewas

Key Responsibilities

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 DESCRIPTION

Job Summary:

Responsible for management of all aspects of Quality Control site. Define operational strategy for quality control management at site. Define site quality control goals and strategy in line with Sun Pharma compliance, product quality management objectives and regulatory requirements. Accountable for Quality of products manufactured and released, monitor overall compliance in the site QC labs.

Proactively assess quality issues at site and ensure compliance to QC regulatory requirements in manufacturing operations at the site and for tracking quality control metrics for alignment with site Supply Chain management and drive them down. Facilitate for all time readiness of the site for any internal and regulatory agency audits at any given point of time.

Essential Job Functions:

• Responsible for defining operational strategy and road map for quality control management at site. Define site quality control goals and strategy in line with Sun Pharma compliance, product quality management objectives and regulatory requirements.

• Effectively manage the site Quality Control activities and resources necessary to smoothly run the QC operation at site.

• Provide strong leadership and expertise to ensure achievement of all Quality Control accountabilities at site.

• Identify and implement solution for improving existing site quality control systems and processes.

• Performance measures are utilized to ensure that departmental activities are effective and timely and as the basis for continuous improvement.

• Coach and develop both direct and, as appropriate, indirect reports through ongoing, example- based performance feedback, annual performance reviews and the provision of training and development opportunities.

• Ensure that performance issues are managed in a consistent and timely manner.

• Develop site quality control revenue and capital budgets and headcount projections, track and manage expenditures and headcount to budget over the fiscal year.

• Responsible for ensuring availability of adequate resources, including manpower to maintain compliance with GXP requirements.

• 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.

• Responsible for ensuring compliance to regulatory requirements on product, process and release procedures.

• Responsible for ensuring smooth collaboration with all Sun Pharma sites and leveraging synergies.

• Accountable for designing/implementing and ensuring compliance to all quality related SOPs, Policies, Standards and QC systems at the site.

• Facilitate internal and regulatory agency audits, ensuring that findings from site QC audits are understood, assessed and addressed site wide in a comprehensive manner.

• Responsible for designing, implementing and ensuring compliance to all quality control related SOPs at site.

• Monitor industry trends/issues faced internally and identify scope for improving Site quality control management and processes

• Responsible for fulfilling all training requirements of quality control employees.

• Identify and implement solutions for improving existing site quality control system and processes.

• Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence. Performs all work in accordance with all established regulatory and compliance and safety requirements.

• Act as System Owner and ensure laboratory computerized systems are validated for its intended use through its lifecycle.

• Ensure the laboratory computerized systems are validated in compliance with the quality policies, standards and procedures and are maintained in validated state throughout the lifecycle.

• Facilitate the user acceptant testing for laboratory computerized systems during validation

• Review and approve Validation and life cycle documentations of computerized systems as per quality procedures.

• Provide support /response to internaI/ external audit observations for laboratory computerized systems and ensure its compliance.

• Ensure resolution of identified risks related to computerized systems in a timely manner.

• Support the assessment and remediation of identified activities as part of various corporate initiatives.

• Ensure GxP computerized systems are compliant to 21 CFR part 11 and EU Annex 11 readiness and adequate security and controls are available to ensure data security.

• Review and approval of all QAMS activity like change control, CAPA, Laboratory events, OOS, deviation, OOT etc.

Customers:-

• Internal: Direct Reports, Regional Head Quality Operation, Head Global Quality , Site Heads & Regional Heads of Manufacturing , Product development, Chemical Research, Regulatory affairs, Legal Affairs R&D Global Material Sourcing, Regional Directors, Country Heads and Supply Chain Managements.
• External: Legal Counsel, Regulatory Agency Inspectors, Consultants, Vendors, and Pharmacopoeia

(USP/EP/IP etc.) Management and Pharmaceutical industry peer leaders.

Travel Estimate

Job Requirements

Educational Qualification

MSc, B.Pharm / M.Pharm

Experience

20+ years of experience in QC

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).