**Job Description Summary** Handling of shift operations, Knowledge about QMS **Job Description** safety: 1. Ensure 100% safe operations within the manufacturing area. 2. Ensure the availability of all required Personal Protective Equipment (PPE) on the shop floor and monitor that personnel consistently wear appropriate PPE during operations. 3. Report all near-miss incidents and ensure timely corrective actions and compliance. 4. Adhere to procedures related to the Environmental Management System (ISO 14001) and Occupational Health and Safety Management System (ISO 45001). 5. Support the implementation of new procedures related to the Environmental Management System. 6. Maintain and follow 5S workplace organization principles. Head count and man power handling: 1. Ensure all the man powers are allocated correctly to their respective areas as per their expertise. 2. Only required head count to plan and 100% utilization of head count. 3. Provide motivation, support and guidance to the team to build a quality working culture. 4. Monitor all shifts in charge reporting system as per requirements. Quality and Compliance: 1. No critical/major observations in GMP regulatory audit i.e. internal/external. 2. cGMP Compliance in entire manufacturing area and SOP compliance on all aspects. 3. Upgradation of system consistently to deliver the quality production, continues improvement to plan. 4. Check all areas log books, BMR entries and all documents calibration records are online and updated. 5. Area up keeping hygiene, cleanliness, all areas are in good condition for 24x7. 6. Ensure proper people, material, scrap, SFG movement to avoid cross Contamination. 7. Ensure proper status labeling of each area, item, equipment, accessories and scrap movement. 8. Ensure proper gowning in the production area, PPE, personal hygiene. 9. Ensure review and acknowledgment of the EMS alarm, power failure, tooling etc. 10. To ensure 100% adherence to the SOP/Batch instructions, specifications, and control parameters. 11. Follow ALCOA++ and ready for any time inspection. 12. To ensure zero overdue on training assigned. Delivery / Dispatches and Plan vs. Actual: 1. Review Production planning on a weekly / monthly / yearly basis according to the forecast /market requirement and complete tasks within the timelines. 2. Ensure day to daily, weekly and monthly target achieve on time delivery / dispatch. 3. Monitor and evaluate of daily/ weekly/ monthly report and conduct micro planning to achieve the target of plan vs. actual with a minimum of 95%. 4. Ensure the availability of machine change parts and accessory items to support for execution of operations. Facility / Area management: 1. Take daily rounds in the production area and plan to ensure 100% compliance. 2. Check production facility, building covings, corners, ceiling, walls, wall guard etc. 3. Ensure every item to be placed in its designated area with proper labeling. 4. Train downline personnel to maintain uninterrupted workflow. 5. Focus on continuous improvements in all means (safety, quality and delivery). 6. Conduct daily, weekly, monthly reviews to assess quality, yield, simplification, documentation,QMS and take appropriate action. Team work and coaching: 1. Ensure efficient collaboration and co-ordination with cross functional departments. 2. Coach team members to solve problems. 3. Mentor team members/ subordinates to maintain good record practices on the shop floor. 4. Communicate concerns related to functional areas to senior management. Key Responsibility: 1. Responsible & accountable as a shift in charge for compliance and delivery. 2. Minimize documentation errors on the shop floor through regular checks and training. 3. Conduct gap analysis of existing SOPs to identify areas for improvement. 4. Develop multi-skilled personnel capable of handling both equipment operations and documentation. 5. Ensure the work area is maintained in a clean, organized, and presentable condition at all times. 6. Drive continuous improvement to maximize product yield and minimize rejection rates. 7. Enhance Overall Equipment Effectiveness (OEE) through proactive monitoring and optimization. 8. Oversee and execute qualification activities and related projects to meet operational standards. 9. To ensure the Segregation, storage and movement of dispensed raw materials. 10. Verification of dispensed materials before start of the operation. 11. Environmental monitoring as per the product specifications. 12. Maintain standard process parameters as per BMRs and other supporting documents for achieving production target and maintaining quality. 13. Responsible for verifying online documentation against the electronic data available in the PLC, including events and alarms during the process. Ensure to verify specified vs actual data recording practices. 14. Initiation of Type A and Type B cleaning line clearances. 15. Ensures that key points and decisions are regularly summarized, and it emphasizes the understanding of critical steps by technical staff throughout the meeting. 16. Ensure to prepare and distribute a detailed agenda before the meeting, outlining key topics and objectives and provide training to the operators daily for CAPA, recent events, DI,GDP and other relevant topics which will boost the awareness on DI for the smooth functioning of department with 100% compliance. 17. Responsible for Validation, Qualification and Calibration of process or equipment's. Handling of all QMS documentation. 18. Responsible for training for new joining, schedule and unscheduled department training. 19. Work with production teams to ensure cost-effective, high quality and timely delivery of products. 20. In process check in manufacturing operation. 21. Swab sample request submission to QC. 22. BMR reconciliation, batch review and closing. 23. Ensure and complete the equipment and instruments calibration, PMP as per the schedule. 24. Responsible for handling critical processes must oversee and guide activities such as recipe loading, binder addition, kneading, loading, AWC, and gun validation etc. 25. Responsible for being especially vigilant during manual operations where electronic data is unavailable and ensuring to witness critical activities such as granulation and sampling. 26. Responsible to perform the supervisor activities. 27. Responsible for reducing changeover time and executing SAP activities. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.