• Managed start to end implementation (Engineering/Feasibility/Scale-up >>> Validation >>> Launch >>> Commercial) of product technology transfers through technical experience, effectively leading multidisciplinary project team in matrix environment, managing client expectation and client relationship management throughout technical transfer process• Key projects managed: Product Technology Transfers, Serialization & Life Cycle (Market Extensions / launches). • Generated key Technology Transfer project documentation including checklist, gap analysis, master plan/scope, status reports, project timelines, task list for project team and maintained project documentation repository. • Lead, organized, tracked, follow-up and monitored project activities to ensure project delivery is on track, in accordance to agreed-upon timelines and provide oversight to planning, execution and closure of each phase in timely fashion. • Chaired and lead project meetings ad managed communications effectively with clients and project teams. • Contributed to the optimization of project implementation processes with efforts to increase project savings on technical side, while maintaining compliance with cGMP and company policies. • Support commercial quotations group with the evaluation of technical costs of product transfers (material, productions schedule, processes and supply costs etc.)• Managed evaluation and resolution of project risks during project life cycle and supported business by keeping the team abreast of technical risks through effective communication.

• Prepared, reviewed, executed and summarized project documentation which includes CR, FS/DS/SDS, control system protocol, vendor protocol, reports• Lead, managed and coordinated project with vendor and key stakeholders• Managed project schedule to meet site’s new product launch deadlines and delivered project on time• Lead protocol development and execution of critical solid dose Equipment Qualification such as Capsule Filling and Closing Machine, Vacuum Transfer Systems, Mills etc. • SME for encapsulation and inspection machines qualification projects.• Inter-department and Intra-department coordination and training of the end user on encapsulation and product inspection systems which includes cross-functional training.• Lead protocol development and execution of Process & Packaging Validation of Solid Dose Manufacturing.

• Responsible for overall validation project management of Processing Vessels and Filling Machine upgrades. • Project involves change management, URS, VPP, FS/DS/SDS updates, drawings updates, CQV, collaboration with vendors and internal departments to ensure smooth transition of the project through various phases. • Review / co-ordination / supervision / preparation and execution of control system protocols, IOQ protocols, PQ protocols, Summary reports and resolution of Non-conformance / Protocol Change Request management • Qualification of the validation equipment (Kaye Validator)

• Prepared, reviewed, executed and summarized project documentation which includes CR, FS/DS/SDS, control system protocol, vendor protocol, reports• Lead, managed and coordinated project with vendor and key stakeholders• Managed project schedule to meet site’s new product launch deadlines and delivered project on time• Lead protocol development and execution of critical solid dose Equipment Qualification such as Capsule Filling and Closing Machine, Vacuum Transfer Systems, Mills etc. • SME for encapsulation and inspection machines qualification projects.• Inter-department and Intra-department coordination and training of the end user on encapsulation and product inspection systems which includes cross-functional training.• Lead protocol development and execution of Process & Packaging Validation of Solid Dose Manufacturing manufacturing process.

• Lead, managed, executed & supported FAT/SAT/IQ/OQ/PQ activities of new and existing equipment and facility• Managed, prepared, reviewed and implemented site equipment requalification program and managed/ coordinated project schedules with other departments to ensure compliance to RQ schedule according to site procedures including resource management• Prepared, executed, reviewed and approved validation protocols for Equipments / Facilities / Utilities / Mapping Studies, Container Closure Studies, Media Fill Simulation studies, Complex Process Automation Systems• Start to End implementation of the Lyophilization equipment and process• Validation Subject Matter Expert (SME) for site Sterilization / Lyophilizer / Process Automation program• Provided Validation Compliance support and guidance to project team / internal departments related to projects and routine manufacturing process• Developed project plans and effective resource management to ensure validation support for projects• Documented validation plans and protocols to ensure process requirements are met• Presented Sterilization / Lyophilization and Equipment Qualification in Regulatory Audits (Health Canada) and various Client audits• Reviewed validation requirements and developed strategies to prevent re-occurance of problems• Ensured that all validation activities are conducted in compliance with cGxP guidelines, site policies, safety requirements and applicable site SOPs. • Developed and maintained site validation program, site validation SOPs• Effectively collaborated with cross functional teams during entire process life cycle• Provided and mentored validation staff as SME• Recognized, reviewed and corrected manufacturing issues for process optimization• Hands on experience in using various validation equipments / tools (e.g. Kaye Validator)

• Hands on experience in organizing and presenting validation studies in Regulatory Audits (MHRA, USFDA, TGA, ANVISA, HPFBI and Corporate Audits)• Developed and maintained validation templates, validation protocols, SOPs• Prepared protocols and reports presentable and defendable in Client / Regulatory Audits with appropriate justifications (based on scientific rationale)• Hands on experience in Process Equipment Qualifications  Steam Sterilizers,  Lyophilizers Isolator Depyrogenation Oven Depyrogenation Tunnel Filling Machine Capping Machine HVAC systems BMS system Terminal Sterilizer• Provided technical support in troubleshooting, investigation, root cause analysis and mitigation plans for validation and process deviations• Hands on experience in writing, reviewing and approving Change Request, CAPAs and Deviations to ensure compliance in organization• Evaluated changes in the established process and determined / implemented validation requirements• Process Hold Time studies• Utility Qualification  Water for Injection (WFI) Compressed Air  Nitrogen Generation  Pure Steam Generation and Distribution• Mapping studies  Warehouse mapping  Freezers Incubators Stability Chambers  Depyrogenation Oven• Start to end project implementation of Terminal Sterilization (Equipment Qualification / Process Development)• Assisted in implementation of Computer Systems (Process Automation & Enterprise Software – LIMS)• Hands on experience in using various validation equipments / tools (e.g. Kaye Validator)