Job Description

Operations Execute the daily scheduled plan. Responsible for shift operations and meeting shift outputs. To maintain inventories, spares related to all equipment\xe2\x80\x99s in Packing Maintain the equipment for cleanliness and smooth operations, timely updates to concerned personnel for any maintenance related work. To ensure maintenance of the premises and equipment in Packing section. To ensure good hygiene of plant and personnel. In-process checks as per SOP/BPR. Reporting any non-compliance to HOD /QA immediately as observed. i. BPR reconciliation. Daily & periodic calibration of equipment (Internal as well as external) Taking overall responsibility for the area and line assigned to them. Manpower Management
Instructs and guides the manpower based on SOPs to ensure the completion of activities related to Tablet Packing. Imparting training to all personnel involved in Packing. ShiftWise work allocation. Compliance
Compliance to all cGMP, cGXP, or any other related requirements, including Zero loss workday case & ensure targeted nos. BBS observation & unsafe condition reporting Complete training on relevant SOPs for Packing. No past due trainings in ISOtrain and Ensure all CAPAs are in place. Ensures online documentation (i.e., equipment logs, batch records, environmental monitoring etc.) correctness of data, compliance to SOPs, Safety and GMP. Handling product as per respective Batch Manufacturing record. Monitors/Conducts in-process checks to ensure all In-process quality parameters are with-in targeted norms. To perform line clearance for respective equipment/area as per respective SOP. Monitors and ensures all the areas and equipment are maintained as per defined procedures for all time readiness for audits by internal/external agencies. Performing all SAP transactions as per defined procedures. Coordination with other departments to ensure smooth operations and compliance. To handle and reconcile stereos as per required SOP

Documentation
Handling, Documentation and Review of BPR and Logbooks as per GDP SOP in Tablet Packing. Preparation and review of all SOPs by drafting based on any new or changed requirement in the process to ensure updation and effective implementation of Packing process. To execute documentation related to production and ensure their strict implementation as per GDP SOP.
Continuous Improvement/Operational Excellence \xe2\x80\x93
Reporting any quality concerns or suggestions to seniors Focus on yield improvements, cost reduction and reduced process cycle time. Identify regular Kaizens in Packing section. To suggest upgradation and automation of systems and equipment\xe2\x80\x99s for Packing section. To maintain OEE and plant cycle time, identification of improvement opportunities and timely updating to HOD for any suggestions/improvement. Monitoring and improving the yields of the products.
Skill, Education, Experience Education: Graduate / Postgraduate (Pharmacy) with 2 to 3 years of experience in Managing Packing operations in Pharmaceutical company. Domain Knowledge: Schedule M, cGMP (current Good Manufacturing Practice) ,21 CFR. KEY COMPETENCIES REQUIREMENTS: Leadership Potential to handle Manpower in Packing Function (2 to 3 years) Managerial Able to Handle all Packing lines during Shift Operation. Behavioral Having continuous improvement mindset.
Handling uncertainty in business
Good communication and collaboration skills.
Team player, collaborative, result oriented.
Actively involved problem solving and providing solutions.
Enforcement and maintenance of high degree moral discipline and technical expertise of the team.