Senior Manager, Manufacturing

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Job Description Summary 1. Responsible & accountable as a lead for compliance. 2. To review and approval of all master document like standard operating procedures, batch manufacturing, incidents/events, process validation, annual product reviews, master datas, protocols and qualification documents. 3. To review the Production planning, weekly / monthly / yearly as per the forecast /market requirement and complete within timelines. 4. Utilization of resources as per the work demand and target timelines. 5. Effective coordination with CFT teams for smooth flow of Manufacturing and Packaging activities. 6. Responsible for QMS compliance & investigation of event , market complaint & effective CAPA closer. 7. Responsible for change control approval, execution and closure cycle. 8. Provide motivation, support and guidance to the team to build a quality working culture. Job Description Safety: To ensure 100% safe operation in production area. Ensure all the necessary PPE's are available in production facility and monitor proper PPE's are worn by the personnel's during operation. Reporting the near misses and ensure their compliance. To follow the procedure pertaining to the environmental management system (ISO14001 & ISO45001). To support in implementation new procedure related to environment management system. To follow and maintain 5S in workplace. Quality and Compliance: No Critical/Major observations in GMP regulatory audit i.e. internal/external. cGMP compliance in entire manufacturing and packaging area and SOP compliance on all aspects. Upgradation of system consistently to deliver the quality production, improvement to plan. Ensure all area logbooks, BMR entries and all documents calibration records area online and updated. Area up keeping hygiene, cleanliness, all areas are in good condition for 24x7. Ensure proper people, material, scrap, SFG movement to avoid cross contamination. Ensure proper Status labeling of each area, item, equipment, accessories, and scrap movement. Ensure proper gowning in the production area, PPE, Personal hygiene. Ensure review and acknowledgement of the EMS alarm, power failure, tooling etc., To ensure 100% adherence to the SOP/Batch instructions, specifications, and control parameters. Follow ALCOA++ and ready for ant time inspection. To ensure Zero overdue on training assigned. Head count and manpower handling: People to follow shifts. Only required head count to plan. 100% utilization of head count. Share a trusting relationship with the work group. Provide motivation, support and guidance to the team to build a quality working culture. Facility/Area management: Check production facility building carvings, corners, ceiling, walls, wall guard etc., Ensure each and every item to be placed in its designated area with proper labelling. Developing down line people so that work should not get affect. Focus on continuous improvements on all means (Safety, quality, and delivery). Monthly reviews to perform Quality, yield, simplification, documentation, QMS, and take proper action. Teamwork and Coaching Ensure efficient collaboration and co-ordination with cross functional departments. Coach team members to solve increasing problems. Mentor team/subordinates in developing documentation. Regulatory interacts with senior management on matters concerning several functional areas, divisions and or customers. Work team COOSST to work efficiently. Involve on culture of excellence implementation and activities.

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