4 Qrm Jobs

Use and understanding of vendor tool called QRM would be a major help. Ability to analyze large data sets using SQL. Write expression and transformation and case statements. Development and modification of reports using Power BI. Exp-4-10Yrs Required Candidate profile • Extensive knowledge and use of python and SQL. • Ability to run a daily process and analyze results of data.

Role & responsibilities: 1 Overall responsibility of Plant Head evaluating plant performance on OEE/OPP/PPM/delivery/ITR 2 Overall responsibility for enhancing customer satisfaction levels in terms of 3 Overall charge of plant administration including Kaizens/Poka Yoka/ best work 4 Pivotal role in system sustenance including DWM/LPA/CM/8D/QRM 5 Responsibility for adherence to TS..... And MSES method in production 6 Overall responsibility for suppling material with zero PPM complaint 7 Plan, organize, direct and run optimum day-to-day operations to exceed our 8 Increase production, assets capacity and flexibility while minimizing unnecessary 9 Participating in the business planning and budgeting of the organization 10 Discussing the production objectives with the senior management 11 Implement strategies in alignment with strategic initiatives and provide a clear 12 Monitor operations and trigger corrective actions wherever needed 13 Share a trusting relationship with workgroup to manage and develop plant staff 14 Collect and analyse data to find places of waste or overtime 15 Commit to plant safety procedures 16 Develop systems and processes that track and optimise productivity and standards, 17 Address employees' issues or grievances 18 Drive quality culture in the Plant 19 Ensure the sustenance of good practices in the Plant 20 Successfully assured the smooth operations by taking preventive & corrective 21 Minimizing inventory of FG/WIP, RM & Components and monitoring order 22 Pivotal role in management of cost realated aspects viz. Yield, Cost of Goods Sold

Strategic: Representative for QMS activities in Drug product/ Drug substance area. Timely initiation and closure of QMS elements. Documentation related to Drug product/ Drug substance area. Training need identification for all the employees Assist the validations and routine validations of equipment and facility. Identify and implement the manufacturing and warehouse procedures with compliance to current GMP requirements. Coordination during customer and vendor audits. Coordinating with engineering and validation department for calibration and preventive maintenance. Coordination and implementation of software based QMS solutions like Track-wise, LMS, SAP etc. Operational: Initiation of change controls, deviations, Investigation and CAPAs and closure of the same. Tracking of QMS activities and coordinating with cross functional departments to complete the QMS activities like investigation for OOS, complaints, deviations. Identification, preparation and implementation of SOP’s. This position will prepare SOPs related to the machines which are undergoing commissioning and procedures which are proposed to implement in Drug product area. Preparation and review of URS, CLIA, SLIA, QRM, IQ and OQ documents. Involvement in the qualification activities of equipment and area in drug product area People: Champion the OneSource Core Values and lead by example by acting a member of a team to achieve organizational and common objectives. Identify business successors and coach, mentor, nurture and develop people towards leading the business as non-fungible assets in the organization with a succession and continuity plan. Preparation and execution of training modules on SOP’s in the department. Preparation and execution of QMS documents in the department. Preparation and execution of training modules on QMS and safety SOP’s in the department. Preparation and execution of training on soft skills to develop the team. Finance: Ensure activities, services and tasks engaged / managed meets or improves on budget, cost, volume and efficiency targets (KPIs) in line with business objectives. Ensure the availability / adequacy of resources to implement and maintain the pharmaceutical quality system and continually improve its effectiveness by applying resources to specific product, process or site.

Purpose of the role: This position will form an integral part in achieving all quality objectives by developing & implementing the current Quality procedures and systems in line with global regulatory expectations and industry practices. Need to work closely with all CFT team in a collaborative manner to build a Quality system. Primary Responsibility: 1. Lead all personnel and processes involved in Inspection and Packaging operations occurring on all shifts. 2. Maintain knowledge of state-of-the-art Biopharmaceutical industry standards and guidelines for inspection and packaging concepts, practices, and processes. 3. Responsible for DP facility packing activities (operation and cleaning of Visual inspection board, Plunger rod insertion & Labelling machine, Cartridge Labelling machine, Blister packing machine, Automatic Cartoning Machine, Pen Assembling and labelling machine, Cold room) related to drug product. 4. Assist the installation and commissioning activities like FAT, SAT etc. of the packing lines for Vials, PFS and Cartridge facility packing. 5. Preparation and review of the URS, QRM, IQ, OQ and PQ protocols for Plunger rod insertion & Labelling machine, Cartridge Labelling machine, Blister packing machine, Automatic Cartoning Machine, weighing balances, Pen Assembling and labelling machine, Serialization etc. 6. Ensure QMS compliance in qualification, visual inspection and packing related activities. 7. Assist the validations of equipment and the process. 8. Identify and implement the visual inspection and packing procedures with compliance to current GMP requirements. 9. Implementation of Track & Trace system for the packaging. 10.Performing the FAT & SAT of packing line equipment at vendor sites or at our facility. 11. Performing/executing the IQ, OQ and PQ related to packaging lines. 12. Performing the visual inspection activities. 13. Assisting the validation activities of other equipment like cold room, pass-box and area. 14. Prepare & review of all SOP`s/protocols related to visual inspection/packing area procedures/equipment and drug product facility. 15. Identify and implement the manufacture procedures with compliance to current GMP requirements. 16. Timely initiation, investigation, impact assessment of QMS elements.