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 current/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 e
📌 AGM- Production- API (India)
🏢 Talental Consultings
📍 India
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