Business: PPL Ennore Department: Production Location: Ennore Job Overview: Pharma plant production operations in compliance to cGMP requirements Travel Requirements : NA Reporting Structure: Role directly reports to - Chief Manager - Production Key Stakeholders: All cross functional teams. & Different Customers and contract manufacturing partners Experience: 10 - 15 Year Experience in manufacturing (API) as per Pharma Manufacturing GMP requirements. Qualification : Graduate in B. Sc/M. Sc (Chemistry) / B. E / B. Tech (Chemical Engineering) / Diploma (Chem. Engg / Petrochemical) Skills and Requirements: Knowledge in Operation of process equipment s & utility systems Good documentation practice & safety practices Trouble shooting of process equipment, and utility systems Handling of solvents / raw materials Handling of hazardous chemicals (Sodium cyanide / Cuprous cyanide/ sodamide / LAH / etc) Compliance to Data integrity Coaching and ensuring safety culture in the team. Monitoring and controlling of process parameter Good house keeping Material management Online documentation Knowledge in ISO 9001, ISO 14001, ISO 45001 Effective utilization of man, utility, equipment, raw materials and power. Knowledge on yield improvement, time cycle reduction, capacity enhancement initiatives Knowledge on generating new ideas and initiatives Key Roles / Responsibilities: Strict adherence to cGMP norms and safety rules of the factory. Planning and execution of the monthly plan / production target. To liaison with engineering and to ensure the minimum down time in the plant. To ensure the budgeted cc s are met and monitor the performance against the budget on a monthly basis for the products produced in the plant. To liason with QA for all plant related activities like deviation change control SOP - preparation & revision, BMR - preparation & revision. To ensure the GMP compliance on the shop floor. To liaison with QC to meet the target and for any improvements. Training of the sub-ordinates (Executives & Team Members) with respect to process & unit operations. To ensure compliance to ISO-9000, 14000&18000 requirement including documentation. Trouble shooting in the process and operation. Implementation of innovative ideas for productivity improvement and cost reduction. Effective utilization of manpower and reduction of attrition. To ensure the energy and utility are used properly and have a better control on use. Process Validation. Ensuring zero non-compliance in external audits. Ensure the New product stabilization and commercialization. Key Roles & Responsibilities 1. Participate and adhere in all EHS continual improvement & line responsibilities (Eg. Emergency mock drill participation, training, permit to work, etc. ) And responsibilities mentioned in the site EHS procedures. 2. Follow all the site safety requirements and exhibit positive behavior in the safety culture transformation. 3. Follow the all permit to work procedure in shop-floor activities. 4. Follow the required Personnel Protective equipment (PPE) usages during performing the shop-floor operations. 5. Identify the unsafe conditions / unsafe acts and report to Manager/EHS team and report any safety-related incidents, accidents, learning incidents or illnesses to the OHC / Superiors / Manager immediately. 6. Follow the previous shift s information / Manager s instructions and complete the assigned tasks, on time. 7. Ensure that executed BMRs, BPRs, ECRs review timely and submit to QA, as soon as possible, based on the requirement. 8. Review & update the shop-floor documents contemporaneously i. e. BMRs, BPRs, ECRs, Logbooks, Protocols, Reports, Checklists, etc. 9. Update the shift logbook as per the process status as well as any priorities or instructions, and hand it to the reliever during the shift change. 10. Impart the trainings on SOPs, revised documents & qualification protocols/ reports to shop-floor personnel. 11. Strictly follow the SOPs on shop-floor. 12. Ensure all the raw material as per RM indent and keep ready for the batches. 13. Raise the work order for maintenance works & coordinate with E&M team for the completing tasks the in time. 14. Co-ordinate with engineering department for performing the scheduled equipment Preventive Maintenance (PM) and instrument calibrations. 15. Ensure batch execution in line with the production schedule. 16. Ensure the cleanliness and good housekeeping in respective areas. 17. Manpower planning to be done based on production priorities, in shifts. 18. Participate in the trainings as per the schedule. 19. In the absence of the Superior, responsible for his work.