Senior Executive, API Production & Process Excellence

Sun Pharmaceutical Industries, Inc.; Indiana (PA); On-site; USD 25,000 - 38,000; Full time

Job summary

Sun Pharmaceutical Industries Ltd seeks a Senior Executive to lead production plant operations at its site in Toansa. The role focuses on delivering scheduled production within quality and cost targets, and on driving waste and water reduction initiatives.

You will ensure regulatory compliance, maintain critical documentation, and oversee CAPA, LMS, and DCM activities. The position requires 12–16 years in an API plant and strong cGMP/FDA knowledge.

Qualifications

• Strong knowledge of cGMP and FDA regulations.
• Experience with API plants and industry best practices.
• Willingness to train and develop subordinates.

Responsibilities

• Responsible for operations of production plant.
• Ensuring delivery of scheduled production as per the plan meeting quality and cost parameters.
• 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.
• Issuance of the Batch Manufacturing Record (BMR) & Equipment cleaning record (ECR) for production of intermediates or APIs according to current SOPs.
• To perform all SAP, TrackWise 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 necessary calibrations and records are maintained.
• Ensuring timely maintenance of equipment & facility and records are maintained.
• 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.
• To ensure necessary Maintenance completion in Plant.
• To ensure that upkeep of plant for all time readiness for inspection.

Skills

cGMP knowledge

FDA regulations

Education

B.E. Chemical

M.Sc. Chemistry

Tools

SAP

TrackWise CAPA

LMS

DCM

Job description

Sun Pharmaceutical Industries Ltd seeks a Senior Executive to lead production plant operations at its site in Toansa. The role focuses on delivering scheduled production within quality and cost targets, and on driving waste and water reduction initiatives.

You will ensure regulatory compliance, maintain critical documentation, and oversee CAPA, LMS, and DCM activities. The position requires 12–16 years in an API plant and strong cGMP/FDA knowledge.