AGM- Production- API

Position- AGM - Production- API Manufacturing
Location- North India

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.
• 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