QC Head; API

Job Title:

QC Head (API)

Business Unit:

Global Quality & Compliance

Job Grade:

DGM

Location :

Panoli

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, youll 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 others journeys.

Accountable for assuring the supply of high-quality, ICH Q7 compliant APIs / bulk drug substances, define operational strategy for quality control system at site, facilitate in finalizing quality control goals, objectives and strategy in line with Sun Pharma compliance, product quality management objectives and regulatory requirements, conduct effective review of the team and portfolio and provide direction and guidance to the team and develop team competence with the objective of ensuring Quality of products manufactured and released with adherence to GMP norms and timelines.

The incumbent will assure individual compliance with the all concerned regulatory requirements, GxPs and applicable department programs, including training, documentation, standard operating procedures, and Sun Pharma policies and procedures.

• Assess and ensure compliance to QC regulatory requirements and track quality metrics and drive them down for API Panoli site .
• Effectively manage the site Quality Control activities and resources necessary to smoothly run the QC operation including release of raw materials, intermediates, inprocess samples, APIs, and monitoring API stability as per regulatory commitments.
• Ensure analytical methods (for intermediates and APIs) are validated/transferred as per ICH Q2 and API regulatory requirements.
• Monitor and review investigations and QMS with adequate CAPA to minimize errors.
• Design, implement and reviews with QC section heads for compliance related to SOPs, policies, standards and quality systems.
• Design and execute continuous improvement initiatives in the site to enhance compliance, drive efficiencies and cost effectiveness.
• Facilitate harmonization and consistent implementation of quality systems and procedures at site, in alignment with regional lobal quality policies tandards.
• Assure all time readiness of site for regulatory agency inspections  nternal audits and appropriate implementation of corrective actions regarding observations made by the agencies  nternal audit teams.
• Facilitate arrangement of all the resources required to QC laboratory to achieve desired productivity, SLA defined as per KPI by continual improving the process excellence.
• Provide strong leadership and expertise to ensure achievement of all Quality Control accountabilities at site.
• 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.
• Ensure oversight of impurity profiling (including genotoxic impurities), residual solvent testing (ICH Q3C), particle size distribution, and API-specific quality attributes.
• 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 compliance to regulatory requirements on product, process and release procedures.
• Responsible for ensuring smooth collaboration with all Sun Pharma sites and leveraging synergies.

B.Pharm / M.Pharm

Tenure: 18+ Yrs

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. Lets create a brighter future together!

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).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical…