API Production Senior Manager

Job Title:

API Production Senior Manager

Business Unit:

API Production

Job Grade

G9

Location :

Toansa

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.”

Key responsibilities:

• Responsible for operations of production plants.
• Ensuring delivery of scheduled production as per the plan meeting quality and cost parameters.
• Ensuring that all the projects are completed in the given time frame and within the allocated resources.
• Evaluating opportunities for reduction of waste generation and water wastage.
• Ensuring availability and updation of all relevant process, regulatory, statutory, engineering documents in the module.
• Ensuring production activities are performed as per approved written down procedures.
• Ensuring the cost of manufacturing is within standard yields & usages and continuous effort to decrease the product cost.
• To ensure simplification and improvement of present manufacturing processes through continuous development work.
• Issuance of the Batch Manufacturing Record (BMR) & Equipment cleaning record (ECR) for production of intermediates or APIs according to current SOPs.
• Reviewing all Batch Manufacturing Record (BMR) & Equipment cleaning record (ECR) and Ensuring that these are completed and signed.
• Preparation/Review of new/revised BMRs/ECRs.
• Preparing & reviewing the validation protocols and reports.
• To perform all SAP, Track wise CAPA, LMS & DCM activities relevant to the job profile.
• Preparation, review & approval of SOPs as assigned.
• Preparing/Reviewing of risk impact analysis, risk assessment & risk re-assessment.
• Reviewing the trend of Quality and production parameters of intermediates & APIs.
• Ensuring that all production deviations are evaluated and investigated as per current SOPs.
• Investigating OOT, OOS & Market complaints of intermediates & APIs and conclusion are recorded on time.
• Planning & implementation of CAPA actions arises out of investigations, observations, risk assessments & regulatory observations.
• Ensuring necessary calibrations and records are maintained.
• Ensuring timely maintenance of equipment & facility and records are maintained.
• Evaluating the proposed changes in the product, process and equipment for quality and productivity improvements.
• Qualifying new or modified facilities and equipment as per current SOPs.
• Ensuring compliance to cGMPs, safety procedures, current SOPs, statutory guidelines and Company’s code of conduct in the plant.
• Training and development of subordinates and indulge in learning and self-development.
• Maintaining discipline, morale, motivation of every employee in plant and maintaining harmonious industrial relations.
• Ensures verification of document destruction records prepared by the document coordinator.
• Preparation and maintenance of annual budget for plant.
• Preparation of Product development report (PDR) and cleaning procedures development report (CPDR).
• To ensure necessary Maintenance completion in Plant.
• To ensure that upkeep of plant for all time readiness for inspection.
• As a Module In charge actively participate in the Internal Audit, Management Review Meeting and Quality Review Meetings

Travel Estimate

Job Requirements

Educational Qualification

B.E. Chemical / M.Sc. (Chemistry)

Experience

Tenure: 20 years to 25 Years in API Plant, Strong knowledge of cGMP, FDA regulations, and industry best practices

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).