Company: Strides Pharma Department: IPQA Profile: - Executive Office Locations: KRSG Plant, Bangalore Qualification – B. Pharmacy/ M. Pharmacy Experience – 2 to 6 years (Must have exposure to OSD) Job Description: • To perform IPQA activities at shop floor in each and every stage of sterile manufacturing and packing. • QA overview for clean room behaviour and aseptic activity. • Review of batch processing records. • Review of all documents relating to the manufacturing, Packaging & analysis report prior to batch release. • Review of documents of respective areas and logbooks for adequacy and completeness. • QA overview for receipt of material from warehouse to production. • IPQA of Dispensing, Manufacturing, Packaging and Dispatch activities. • Review and Control of SOP’s, Specification, BPR issuance, Master Formulae and Records. • Preparation & Review of process validation protocols and reports. • Executing the validation/revalidation activity in the absence of authorized person. • Any job activity assigned by HOD • Responsible for regulatory audits with exposure equivalent to WHO Geneva PQ/USFDA Competencies: • Execute IPQA Excellence by setting clear benchmarks. • Smart Thinker and displays smart/ tactical moves & mental agility. • Is open and flexible when faced with changing circumstances and finds ways and means of doing things and not get struck with the past. • Comes up with ideas which are different and can be used commercially, profitably and growth. • Support and guide subordinates by giving appropriate examples & feedback. Encourage team to come up with new ideas. • Proposes solution which has elements of sustainability.

1. Monitoring shop floor ASD & FD execution activities and ensuring compliance and adherence to quality systems at all levels of development. 2. Review and approval of AMV, AMD, AME & AMT Protocols and Reports. 3. Review & Authorize Specification and standard test procedures for API, Finished product, excipients, consumables and packaging materials. 4. Receipt, numbering and circulation of API DMF. 5. Authorizing creation of item codes/SFG/FG/consumer code requests and related documentation. 6. Review & approval of Formulation Development associated documentation like PDP, PDR, MFR, SDS, QRM, PEEB, PETBs, Stability protocols of all R&D studies. 7. Review and approval of Packaging development documents Viz.; PKDR, MPRetc. 8. Review and approval of all MS&T and Site transfer related documents. 9. Assessment & approval of Impurity Assessment reports like Nitrosamine, Elemental impurities & residual solvents.

Company: Strides Pharma Department: Quality Control Position: Executive Job Location: KRSG Plant, Bangalore Qualification: M.Sc. (Chemistry), B-Pharm, M-Pharm Experience: 2 to 6 Years Key skills: • Analysis of Material / Product by referring current version of specification STP with relevant material code. • Responsible for initial set up of Instrument/Equipment before starting the analysis with relevant online entries in usage • Log / LIMS. • Perform the Assay and RS by LC/UV/Dissolution, content uniformity by LC analysis with simple and complex products • Tests as per SOP/STP. • Proper handling of chromatographic column used for analysis. • Maintain data integrity and appropriate traceability

GRN processing for Raw Materials and Packaging Materials. To dispense RM and PM as per days plan. Planning and execution of sampling and dispensing activities of Raw Materials and Packaging Materials. Preparation and implementation of SOPs for warehouse activities. To update records pertaining to WH activities. To ensure periodical cleaning activities of Goods lift, racks, weighing balances, pallets, vacuum cleaner return air raiser filters, scissor lift, mobile stackers and manual hand pallet trucks. To follow safety procedures as required.

SAP(MRP) Material Requirement Planning(RM & PM Planning – 4 to 5years) -Inventory Management Inventory Management • Translate the demand to Purchase orders/Sales order scheduling to the plant and help in ensuring that the inventory levels are optimized between 2+3 model in the front and transit ensuring MOT is always sea. • Work on various matrix to ensure the sales team gets feedback on actuals vs forecast and keep the cross functional team abreast. Additional Business Opportunities and New Launches • Co-ordination with stake holders to decide on acceptance/start date for additional business opportunities and successful new product launches Order Book Management • Ensure that SO is placed aligning with customer PO requirements including qty, pricing, batch size details Quality and Compliance • Complete SOPs and trainings on time Supply Chain Process Improvement and MIS • Identify areas to improve supply chain processes and establish benchmarks and strategies for the improvement in a phased approach • Adopt automation for efficient inventory monitoring and management.

Key Responsibilities (in brief): Experience in Demand & Supply Planning (Min 3-4 years in Demand planning & with strong analytical skills); • Coordination with Business Finance team for the monthly rolling forecast. • Generate Net Requirement planning based on Forecast, Opening stocks, Transit stock, Mfg. Campaigns • Collaborate with Mfg. sites & Monitor plan vs actual performance on a weekly and monthly basis to ensure Delivery in Full, On Time (DIFOT) targets are achieved. • Collaborate with the logistics team to develop dispatch plans and oversee in-transit shipments and arrivals. • Monitor key and critical products with end-to-end tracking to prevent stockouts Materials Planning: o Derive at actual shortages and accordingly raise purchase requisitions in plan visage through MRP. o Raise manual PRs for materials with higher lead time and upcoming expiry with due approvals System Hygiene for PR/PO/SO and creation of FG planned orders: o Maintaining hygiene in the system by cleaning up unpegged Purchase orders, manual purchase requisitions, sales orders and creating FG planned orders Artwork Management: o Review change in artworks and take call on destroying the materials or use stocks for current orders. Intimate PDC for MPR revision. RM Expiry and Revalidation: o Checking on expiry and revalidation of API's and Excipients quarterly and plan fresh materials whenever needed. Inventory Management • Monitoring of sales/Fill rates & stock status to ensure optimum inventory levels at all the times. • Translate the NRP output to Purchase orders/Sales order Additional Business Opportunities and New Launches • Co-ordination with stake holders to decide on acceptance/start date for additional business opportunities and successful new product launches Order Book Management • Ensure that SO is placed aligning with customer PO requirements including qty, pricing, batch size details Quality and Compliance • Complete SOPs and trainings on time Supply Chain Process Improvement and MIS • Identify opportunities to enhance supply chain processes and set benchmarks and strategies for gradual improvement • Adopt automation for efficient inventory monitoring and management

2. Develops project plans for all aspects of assigned projects and manages all project activities. 3. Define projects scope, goals and deliverables that support business goals in collaboration with stakeholders. 4. Establishes and leads cross functional project teams and status meetings. 5. Obtains consensus and buy-in from key internal and external stakeholders for project timeline and review of project progress to ensure deliverables on time. 6. Conducting the kickoff meeting with all stakeholders and subsequent circulation of project timelines amongst the responsible and accountable stakeholders. 7. Monitors and manages project scope, forecast, resources, and deliverables within timeline. 8. Maintains up-to-the-minute project action plans and serves as a resource to stakeholders. 9. Ensures all stakeholders receive the required level of detail commensurate with their role. 10. Provides input on strategic goal, tactical planning, and high-level staffing plans. 11. Proactively identifies significant project risks, develops mitigation strategies, escalates to leadership, and implements approved mitigation steps. 12. Develops and maintains subject matter expertise to effectively plan and fully execute assigned projects. 13. Work allocation and Co-ordination with cross functional teams. 14. Identify and resolve the issues and conflicts within the project team. 15. Presenting the project status/progress to senior leadership team in scheduled fortnight or monthly meeting. 16. Liaising with other functions; like Quality, Supply Chain Management, Packaging Development, Analytical Developments, Site QC, QA, MS&T etc. to ensure smooth progress of the project. 17. A proven record of accomplishments in continuous improvement events/projects, team leadership and problem solving/trouble shooting, demonstrated success initiating change and influencing at all levels 18. Hands on experience on complex projects, in handling larger product portfolio with multi-disciplinary cross functional teams and ownership. 19. To possess good communication skills to interact with various CFTs & partners and external vendors

SAP Master data Creation, Maintenance & Supportive role with respect to Material, Vendor, Customer Master in SAP ERP applications which includes product data cleansing, interacts significantly with fellow stakeholders across Quality, Purchasing, Supply Chain, Finance and Plant Operations. Expected to have a better knowledge around material master creation and maintenance process in the SAP ERP system. SCM SOPs preparation, revisions, and training. Should have enough expertise to support supply chain business process and contribute in enterprise wide initiatives from a data perspective. Exposure to Change controls , Deviations, CAPA activities in Track Wise applications with respect to SCM & SAP functionalities. Validation activities with respect to SAP SCM related Master Data activities in relevant applications.

Company: Strides Pharma Department: IPQA Profile: - Executive Office Locations: Alathur Qualification – B. Pharmacy/ M. Pharmacy Experience – 2 to 6 years (Must have exposure to OSD) Job Description: • To perform IPQA activities at shop floor in each and every stage of sterile manufacturing and packing. • QA overview for clean room behaviour and aseptic activity. • Review of batch processing records. • Review of all documents relating to the manufacturing, Packaging & analysis report prior to batch release. • Review of documents of respective areas and logbooks for adequacy and completeness. • QA overview for receipt of material from warehouse to production. • IPQA of Dispensing, Manufacturing, Packaging and Dispatch activities. • Review and Control of SOP’s, Specification, BPR issuance, Master Formulae and Records. • Preparation & Review of process validation protocols and reports. • Executing the validation/revalidation activity in the absence of authorized person. • Any job activity assigned by HOD • Responsible for regulatory audits with exposure equivalent to WHO Geneva PQ/USFDA Competencies: • Execute IPQA Excellence by setting clear benchmarks. • Smart Thinker and displays smart/ tactical moves & mental agility. • Is open and flexible when faced with changing circumstances and finds ways and means of doing things and not get struck with the past. • Comes up with ideas which are different and can be used commercially, profitably and growth. • Support and guide subordinates by giving appropriate examples & feedback. Encourage team to come up with new ideas. • Proposes solution which has elements of sustainability.

Company: Strides Pharma Department: Quality Control Position: Executive Job Location: KRSG Plant, Alathur Qualification: M.Sc. (Chemistry), B-Pharm, M-Pharm Experience: 2 to 6 Years Key skills: • Analysis of Material / Product by referring current version of specification STP with relevant material code. • Responsible for initial set up of Instrument/Equipment before starting the analysis with relevant online entries in usage • Log / LIMS. • Perform the Assay and RS by LC/UV/Dissolution, content uniformity by LC analysis with simple and complex products • Tests as per SOP/STP. • Proper handling of chromatographic column used for analysis. • Maintain data integrity and appropriate traceability

Cross-Functional Collaboration: Collaborate with R&D, manufacturing, and marketing teams to integrate regulatory considerations into the product development and commercialization processes. Regulatory Submissions: Oversee the preparation and submission of all necessary regulatory new dossier filings, and variations, to relevant health authorities in the targeted regions. Market Intelligence: Monitor and analyze evolving regulatory landscapes and market trends to proactively identify opportunities and challenges. Stakeholder Engagement: Build and maintain strong relationships with regulatory agencies, industry associations, and key stakeholders to facilitate smooth regulatory processes. Team Leadership: Lead and mentor a diverse team of regulatory professionals, promoting a culture of excellence, compliance, and continuous improvement. Compliance Oversight: Ensure all regulatory activities adhere to internal policies and external regulations, managing audits and inspections effectively.

1. Good Documentation Practices, Compliance for Standard Operating Procedures, Quality Management Systems shall be followed. 2. Review and understanding of product related technicalities for smooth transfer of products to Internal Manufacturing facility of Strides or External Facility. 3. Co-ordination and collection of technical documents from internal sites. 4. Review of Tech pack documents and sharing (MFR, MPR, Spec/STP, BMR, BPR, Tool drawings layouts etc.) to Internal or external manufacturing sites. 5. Review of Master documents before initiating validation batches at Internal or external manufacturing sites. 6. Handling of Investigation related to OOS/OOT/Deviation occurred/reported for New Products and Site Transfer Projects. 7. Conducting/Monitoring of Feasibility trials/ Scale up trials at R&D or Manufacturing site. 8. To be involved in cost improvement program for identified product, to change the formula and improvise the process as required. 9. Handling of Product Robustness Projects and related activities like conducting the trials at R&D, Execution and Monitoring of Optimization batches and Registration/Commercial batches for PR projects. 10. Handling of Trouble shooting to improve the product quality attributes. 11. Review of APQR, RCI, CAPAs, PDR and other related documents. 12. Handling of QMS events (CC/Deviations) in Trackwise. 13. Ensure Test license availability at R&D & Plant. 14. Ensuring Toolings and RMs availability for execution of lab trial batches, PO/PE/Scale up batches and monitoring the batches during execution. 15. Preparation and Review of Trial Reports, and Investigational Summary Reports. 16. Preparation and Review of Documents i.e. MFRs, BMRs, BPRs, Protocols/Reports, QRM for Trial/Feasibility, PO and New Products, various batch sizes and subsequent revisions of all kinds. 17. Review & Approval of PVP & PVR. 18. Preparation and review of stability protocol for experimental batches. 19. Initiation/approval of the test request for the analysis. 20. Process optimization activities for internal/external products as identified and assigned. 21. GMP, GDP, Quality Management systems and SOP shall be followed to ensure the continuous compliance.