Harshad Kakade

To achieve a professionally challenging position in the world of pharmaceuticals by benchmarking performances and contributing significantly to achieving the organizational goals.

12 years + of experience in pharmaceutical Formulation Manufacturing & Packaging Operations, Audits and compliance; Operational Excellence; MSAT; Validation; COG’s Management; Trouble Shooting; Capacity Enhancement; Catered the best quality products to the world’s Regulatory, Domestic & ROW market; Leading projects from inception to successful completion.

• 4 Localisation products Successfully established at Sri Lanka for CIPLA among which 2 approvals from NMRA received
• Lead 12 Operational Excellence projects for site transfer & trouble shooting [5 to 10%] & process time reduction [20 to 30%] completed successfully at Cipla from 2020 till date.
• Having track record, completed 50 plus tech transfer projects of OSD dosage forms successfully with in committed time line.
• Successfully Faced audits as core member of CFT team for USFDA – USA, MHRA – UK, TGA – Australia, MCC – South Africa, MCA -Zimbabwe, ANVISA – Brazil, and WHO-Geneva

• Assistant Manager, CIPLA, Mumbai, India, 06/2020, Present, Tech Transfer -RM/PM Procurement ,Packing Change Part , Punch set Procurement and tracking Manufacturing & Packaging planning & ensure dispatch on time; Ensure trouble-free Manufacturing, Packaging & Testing; Ensure QMS compliance - Audits and compliance [Internal & External]; Change management; Incident Investigation; Market Complains & CAPA management compliance Weekly QMS meeting with RA, BD, QA, QC & Production. Handle daily planning meetings with PPIC, SCM, WH, Production, Packaging & QC; Regulatory & Customer query response; Based on need meetings with customer; Monthly OE meeting; QRM & ORM with management; Ensure cGMP compliance at site; Man Power management & CFT communication; Weekly New products planning with CMOs, R&D & Projects team – scheduling and execution of filling batches; Ensure Documentation review, and approval; cGMP, EHS Training for new employees. Ensure compliance as per 6 Sigma practice and Data integrity as per ALCOA+ principles. Risk Assessment: Identify stage wise product robustness related issues and challenges pertaining to particular CQAs (PSD, Appearance, Impurities, Dissolution, Yield) in commercial basis market complaints, OOS, CPV, process capability index along with Manufacturing and Quality Teams. Identify new technologies, automation and mechanization opportunities related to new equipment and material handling solutions to reduce process time, enhance capacity, and minimize human efforts and avoid human errors. Product re-development with respect to process & Formulation as per SUPAC guideline: Ensure trouble-free new product formulation development, technology transfer - Manufacturing, packaging Testing and documentation with in committed time line. MSAT: Technology Transfer from R&D and customers - Review PDS, Tech Transfer Pack, risk assessment, batch size proposal, AMV, validation protocols, reports. Trouble shooting: Responsible for process improvements of existing products and new products. Work on product robustness. Conduct detailed investigation and identify root-cause(s) for failures using different techniques and correlation of CPPs or CMAs or any other characteristics with Impacted CQA. Develop and implement CAPA and its effectiveness. Identify Technical equipment Challenges pertaining to flow of the product like equipment setting, material flow ability, frequent deviations in manufacturing process resulting in delays. Develop scientific and technical solutions to address such issues. Responsible for investigations related to process non conformances (NSQ’s). Achievements: Resolved technical challenges for during site transfers at CMOs’, based on requirements proposed Equipment minor modifications, Process & Formulation minor changes, addressed with equipment requalification, as per SUPAC guideline. Ensure timely Customer query response. Trouble-free, feasible technology transfer from R&D & Customer, of different dosage forms [OSD, Liquid,] Site capacity enhancement by Equipment’s automation modification, Training, Process improvement, Analytical testing method improvement, reduced technical challenges & Batches failures.
• Executive, Mylan Laboratories, Aurangabad, 04/2018, 06/2020, Planning and execution and monitoring and Trouble shooting of Scale-up / Developmental Trial / Characterization/ Exhibit(ANDA)/ Process optimization/ validation batches. Formulation & Development of various formulation like Tablet, Hard Gelatin & Soft Gelatin Capsule, pellets, Granules of General OSD products and Handling experience of Tablet & hard Gelatin capsule . Development in various released pattern like Controlled release, modified release, Delayed release, Sustained release. Reformulation and trouble shooting of existing products by taken different vendor trials in pilot scale and commercial. Handling various new development trials for Generic Formulation for ANDA submission/filing. To execute all shop floor activity to manufacturing the products as per GMP requirement. To execute scale-up/process optimization and exhibit/validation batches of in-house new products as per Regulatory requirement. To check & carry out feasibility of new Technology Transfer/Development project. To implement of required changes in the product or process as per product performance or proposals and evaluate the cost effective process and changes in raw material vendor. Preparation Technology Transfer/Study protocol & Report for Scale-up/ Development trial/ Characterization batches. Preparation of Executed batches Justification report / OOS /OOT reports as part of formulation requirement. Handling of Troubleshooting of product and technical support to during manufacturing of Formulation & raw materials testing, In-process & Finished products. To planning the documentation as per requirement of proposed products and follow up for submission Documentation. Execution and continuous monitoring of In-Process testing like physical parameters testing of new Tech Transfer/ Development projects and Compilation of Scale-up/ Trial/ Characterization/ Exhibit (ANDA)/ Process optimization/ validation batches data. Managing the production activity as per project requirement. Support plant for resolution of technical issue and in trouble shooting at shop floor. To carry out Inter Departmental and external client communication.
• Senior Officer, Indoco Remedies, Goa, 07/2016, 04/2018, Planning and execution and monitoring of Scale-up /Exhibit (ANDA)/Process optimization/ validation batches. Formulation & Development of various formulation like Tablet, Capsule, Sterile formulations ( Injectables &ophthalmic preparations ) , Granules. Development in various released pattern like Controlled release, modified release, Delayed release, Sustained release. Reformulation and trouble shooting of existing products by taken different vendor trials in lab scale and pilot scale. Handling various new development trials for Generic Formulation for ANDA submission/filing. To execute all shop floor activity to manufacturing the products as per GMP requirement. To execute scale-up/process optimization and exhibit/validation batches of in-house new products/site transfer products as per Regulatory requirement. To check &carry out feasibility of new Technology Transfer/Site Transfer project. To implement of required changes in the product or process as per product performance or proposals and evaluate the cost effective process and changes in raw material vendor. Preparation Technology Transfer Protocol & Report for Regulatory Markets like US/Europe/Australia/South Africa. Evaluation of Raw materials (API/Excipient) for new product with their specification and additional requirements. Handling of Troubleshooting of product and technical support to during manufacturing of Formulation & raw materials testing, In-process & Finished products. To planning the documentation as per requirement of proposed products and follow up for submission Documentation. Execution and continuous monitoring of In-Process testing like physical parameters testing of new Tech Transfer/ Site Transfer projects and Compilation of Scale-up/Exhibit (ANDA)/Process optimization/validation batches data. Handled the Process Development lab new area requirement like Equipment set up, dealing with different vendor of equipment, installation & qualification of Equipment/ Instruments, Preparation of SOP and Maintenance of record of the same. Monitoring Packing activity (Blister Pack, Bulk Pack & Bottle & Tube Filling etc.) as requirement. Managing the production activity as per project requirement. To implement Process Development and improve in the area of cost and quality. Support to plant for resolution of technical issue and in trouble-shooting at shop floor. Documentation, Day to Day planning, Resource planning & Literature survey. Interacting with overseas customers in the process of decision making as per product requirement. Attaining project meeting, telecoms and initiate the activities accordingly. Preparation and review of various SOP’s in TT dept. To carry out Inter Departmental and external client communication. Faced regulatory Audits - USFDA – USA, EU
• Junior Officer, Sterling Healthcare Pvt Ltd, Pune, 08/2015, 07/2016, To support for planning, timely execution& implementation of Production activities. To execute all shop floor activities . Preparation and review of various SOP’s. Monitoring & Executing the activity such as granulation & compression. To carry out Inter Departmental and external client communication.
• Chemist, Medispray Laboratories, Satara, 09/2010, 02/2011, To support for planning, timely execution& implementation of Production activities. To execute all shop floor activities . Preparation and review of various SOP’s. Monitoring & Executing the activity such as granulation & compression, coating. Working out & Preparation of Placebos

Manufacturing Planning; Man power management; Project management; Site Capacity Enhancement; External Contract CMO Co-ordination, Procurement, R&D Coordination , US Market commercials supply, SUPAC Validation; DOE, QBD, Product technology transfer from formulation development stage to site; Pilot Scale process Optimization, Exhibit, Launch batches Validation; Technical Support to Regulatory filing and response., Audits and compliance [Internal & External]; Change Control; Market complains, Incident; Deviation; Investigation; Risk assessment; CAPA;

• OSD – Tablet IR, ER, SR, MR, Film coated, Pellets, Granules, Hard gel Capsules
• Sterile – Injection Packaging - Blister, Strip, Bottle, Bulk Pack

V0891622

Date of Birth: 10/19/1987

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I hereby declare that the information provided is true to the best of my knowledge and belief.