Designation: Assistant Manager Experience: 5-8 years’ experience Industry background: Mandatory hands-on experience of packaging material procurement/ sourcing in Pharma industry . IIP background will be an advantage Key Responsibilities: Will be responsible for creating purchase order for R&D / Commercial Responsible for delivery of PPM & SPM for R&D / Commercial Payment tracker to maintain. Cost sheet to maintain. Quality agreement/ CDA to initiate. New vendors to source/ Alternate vendor to develop. Supporting Team in all procurement activities. Key Skills : Passionate for packaging material. Adept Learner Team Player Good Communication skills Integrity Good technical knowledge of Packaging material

ROLE PURPOSE Responsible for the procurement of Raw Materials for commercial production of injectable business. KEY DUTIES AND RESPONSBILITIES Ensuring supply of raw materials i.e. APIs & Excipients for commercial production aligned with Business and Purchasing strategies. Techno Commercial Negotiations with vendors ensuring cost, quality, service targets and standards are achieved demonstrating competitive advantage to the Business as a result. Cost Saving. Vendor management. Alternate vendor development. Supply risk evaluation and mitigation. Execution of CDA, Quality Agreement & Supply agreements with key suppliers and arranging vendor qualifications and audits. Coordination with cross functional teams like RA, QA, QC, R&D, Project Management team, Manufacturing, Finance, Planning, Warehouse/ Stores for smooth RM supply. Arranging Purchase Orders and managing deliveries at site with required quality, quantity and on time. Enabling qualification of change notifications, independently interacting with cross functional teams for qualification of change. Handle & closure of OOS, Deviations, QMS/Supply queries against the raw material delivered. Maintaining OTIF for all the material procured.

If you are looking for the right opportunity to start your career in the pharmaceutical industry, this is the perfect chance to begin your professional journey We are offering a yearlong Apprenticeship to Freshers for the below Departments and Qualifications. Manufacturing - B. Pharma/ M. Pharm Warehouse - B. com Microbiology - M.Sc. Microbiology Engineering & Projects - B.E or B. Tech Mechanical Packaging Device Development - B. Pharm/ M. Pharm/ M.Sc. (Chemistry) Work Location - Bilekhahalli, Opp. IIM Bangalore, Bangalore *Requirements to Apply* This opportunity is specifically for Freshers with the above-mentioned qualifications only Only candidates who have completed the course and have their Final marksheet/Provisional certificate/Degree certificate will be considered In case of any prior experience, the candidate should not have been covered under the ESI (Employee State Insurance) or PF (Provident Fund) If you are eligible and are interested to apply, You can share your CV/Resume to *Applying to this opportunity does not guarantee permanent employment. *The Hiring Team (TA, Hiring manager or HR) reserve rights to not consider/ reject any misfit candidate.

Should have 3-7 years’ experience in Quality control Testing of Raw materials and Finished products Testing of stability samples Handling of HPLC & GC instruments Handling of Chromeleon software Handling of UV, TOC, FTIR & Auto titrator instruments Instrument calibrations & trouble shooting Handling of LIMS Should have knowledge on GMP/GLP Should have knowledge on OOS/OOT/Deviations/Laboratory incidents

Purpose of the role: Drug Product MSAT and Technology Transfer TECHNICAL COMPETENCIES: 1. To ensure Site / Tech -transfer of products to Manufacturing site. 2. To ensure Process Performance Qualifications Role Purpose: 1. Technology transfer of in house R&D developed products. 2. Product transfers from internal and external sites to CDMO. 3. Ensure the compliance of Relevant SOPs in product transfer process. KEY DUTIES AND RESPONSIBILITIES: 1. To involve in execution of feasibility/exhibit/pre-validation/process qualification batches for 2. Technology transfer of products and site transfer products. 3. To conduct trials required to generate additional information or knowledge to support the site transfer projects. 4. Responsible to follow EHS compliance as per the site EHS policy and manual. 5. Responsible for review and approval of process performance qualification and continuous 6. process verification protocols and reports. 7. Supporting the operations team for closure of deviations by involving in investigations for commercial batches. 8. Responsible for MFR review. 9. Responsible for preparation of BMP / Trial report. 10. Responsible for Gap analysis preparation. 11. Responsible to ensure product execution checklist for new products. 12. Preparation and review of protocols or batch records for trial batch on need basis.

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.

Purpose of the role: Responsible for stability Management Primary Responsibility: Strategic: 1. Ensure 100% compliance to usage of Quality systems. Operational: 1. Adherence of cGMP (Current Good Manufacturing Practice) and cGLP (Current Good Laboratory Practice). 2. To have control and ensure the Stability team management. 3. To ensure the stability samples are analyzed and released as per schedule. 4. To ensure none of the stability samples are being crossed the window period. 5. Review of Stability samples in quality control department. 6. Instrument/Equipment qualification Review in Quality control. 7. Preparation and maintenance of quality records and study protocols. 8. Preparation of quality system related, Instrument operation related SOPs, Specification, STPs, URS etc. 9. Coordinate with cross functional teams such as Production, QA, Warehouse, SCM etc. 10. Review of method transfer and method validation in quality control. 11. Handling of QMS elements related to quality control. 12. Maintenance and calibration of instruments in Quality control. 13. Quality Interface in audits (both internal and external) and ensure appropriate QMS document identified in a timely manner and closed out. 14. Analysis of vendor samples and reporting. 15. Follow approved STPs, SOPs, and Specifications 16. To ensure readiness for Customer and regulatory audits. 17. Providing the support to meet the management objectives of product deliveries on time in line with Quality Management system. 18. Support quality related activities in other sites of Stelis (as required)

Purpose of the role: Responsible for all areas of the Engineering function of DS block and Water System. Primary Responsibility: Strategic: • To conduct Periodical plant energy audits to improve the efficiency of the system & to bring down the operating cost. • Plant upgradation works planning, execution on periodical basis. • Plan & work towards the target set by the management based on business needs. • Updated & aware of cGMP requirements. Operational: • Operation & Maintenance of Utility equipment’s – Boiler, Chiller, Hot water system, Cooling tower, Air compressor, Pumps, Valves, Piping system. • Operation & maintenance of clean Utility equipment’s: Raw water storage & Distribution system, Water Pre- Treatment system, Softener, Purified water generation, Water for Injection generation, Pure steam generation along with Storage & Distribution system. • Attend to Preventive & Breakdown maintenance for Plant & Process equipment’s related to Drug product- Filling lines, Autoclaves, Manufacturing/ Filtration vessels, CIP, SIP, TCU, Autoclaves, Packing machine, etc. Drug Substance- Fermenters, Centrifuges, Homogenizers, HPLC columns, Filtration vessels, CIP, SIP, TCU, Autoclaves, etc. • Gas distribution systems. • Mechanical maintenance support Fire protection systems. • Mechanical support for ETP & STP. • HVAC, BMS, EMS systems. • Good Documentation practices. • Monitoring of outsource agency for plant operation. Review & coordinate for finalization of agreements. • Preparation/Review/Training of SOP, Preventive Maintenance, Break down Maintenance, Schedule, Planning. • Knowledge of plant safety & cGMP requirements. Audit & Statutory Compliance. • Coordination with user departments & plan for Preventive/Breakdown maintenance. • Ensure smooth operation of plant & machinery to avoid breakdowns & production loss. • Plan for required spare parts inventory & AMC. • Shift scheduling, Manpower planning & reporting. • Computer skills including Auto CAD, Microsoft Projects. • Prepare/ Review/ Execution of SLIA, URS, DQ, QRM, CLIA, FAT, SAT, IQ, OQ & Support for PQ. • Goal settings to team members & annual review. Providing the same to department head for review & approval. • Responsible for handling of controlled documents such as SOP’s, logbook and qualification protocol etc., • Responsible to ensure preventive maintenance of the equipment is completed as per schedule and review the preventive maintenance schedule as per SOP. • Prepare/ Review/ Execution of SLIA, URS, DQ, QRM, CLIA, FAT, SAT, IQ, OQ & Support for PQ including EDMS documentation

Lead Quality Assurance operations, ensuring compliance with GxP and continuous improvement. Oversee Quality Systems to maintain compliance with regulatory requirements and procedures. Ensure timely execution of Quality Assurance activities, including Change Controls, CAPA, Deviations, OOS, OOT, and Market Complaints. Represent QA during regulatory/customer audits, track compliance plans, and implement corrective actions. Monitor the effectiveness of CAPA programs and ensure accurate implementation. Facilitate batch review and release per regulatory requirements. Investigate and resolve non-conformances, ensuring appropriate corrective and preventive actions. Ensure execution of Annual Product Reviews and escalate recommendations to senior management. Maintain adherence to safety, data integrity, and ethical conduct policies. Oversee in-process Quality Assurance (IPQA) for compliance with shop floor activities. Review and approve key documents across Production, Warehouse, Quality Control, Engineering, R&D, and EHS. Participate in cross-functional meetings, ensuring alignment on quality, compliance, and process improvements. Support sterility assurance programs, media fills, and aseptic process monitoring. Coordinate internal audits and ensure timely resolution of observations. Monitor and enhance aseptic practices in the manufacturing environment. Ensure timely investigation and resolution of customer and market complaints. Provide batch disposition decisions and approve release documentation. Ensure timely submission of required documents to regulatory and cross-functional teams. Prepare and review protocols, procedures, and QMS elements to sustain compliance. Identify training needs for QA team members and conduct required training programs. Lead quality discussions in periodic review meetings, supporting compliance and process improvements. Track and monitor timely closure of deviations, root cause investigations, and CAPA. Ensure timely resolution of queries from customers and third-party review teams. Promote continuous quality improvements through effective cross-functional collaboration. Promptly report and escalate non-conformances or critical quality issues for assessment.

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.

Strategic: Work towards continues improvements in automation & instrumentation to bring down the cost and technology advancement. Plant upgradation works planning, execution on Periodical basis. Able to visualize & plan the activity related to overall Project execution. Plan & execute the work towards the management goals. Able to handle DS and DP equipment’s Updated & aware of GAMP5, cGMP, statutory guidelines & standards requirements for automation and instrumentation. Plan for implementation of Automation layers Aware & update the latest software related to Automation & Instrumentation, DP, DS. Operational: Monitor the overall activity of Automation and Instrumentation activities. Plant level Automation and instrumentation breakdown diagnostics and maintenance for DP, DS, QC, EMS, BMS & Utilities. Support to Automation Layers implementation and validation. Calibration management including planning, execution, documentation and control for the plant level. Automation to support for upstream and downstream processing of MAbs/therapeutic proteins such as microbial, cell culture, chromatography, TFF, blast freezing, CIP/ SIP etc. Technical site support for CCTV, Access control, Door interlock. However main responsibility of maintaining & trouble shooting, planning & execution rests with facility management department. Coordinate with EHS team for trouble shooting of Fire alarm, PAS, VESDA & Gas suppression system. Technical site support for IT team for Data & Internet connectivity. However, main responsibility of maintaining & trouble shooting, planning & execution rests with IT department. Preparation/Review of SOP, Preventive Maintenance schedule/planner, Documentation etc. Coordination with user departments & plan for Preventive/Breakdown/ Calibration maintenance. Ensure smooth operation of plant & machinery to avoid breakdowns & production loss. And Coordination with user departments & plan for Preventive/Breakdown maintenance. Monitoring of outsource agency for plant operation. Review & coordinate for finalization of agreements. Preparation/Review/Training of SOP, Preventive Maintenance, Break down Maintenance, Schedule, Planning. Support Audit & follow Statutory Compliance. Review & approval of P & ID along with control & function layout drawings and electrical drawings. Prepare/ Review/ Execution of SLIA, URS, DQ, QRM, CLIA, FAT, SAT, IQ, OQ & Support for PQ. Monitoring of outcome agency for plant operation. Review & coordinate for finalization of agreements. Preparation and execution of QMS documents in the department. Goal setting to team members & annual review. Providing the same to the department head for review & approval. People: Shift scheduling, Manpower planning, reporting & Shift operations. Contract / Service provider Manpower/activities planning, reporting.