Abhay Inamdar

I successfully advanced the operational efficiency of Immacule Lifesciences by leading critical engineering projects and compliance initiatives. • Spearheaded the qualification of advanced manufacturing lines, ensuring adherence to stringent regulatory requirements. • Collaborated with regulatory consultants to implement CAPA actions and enhance audit responses. • Drove the digitization of equipment qualification protocols, improving operational workflows and compliance tracking. * Spearheading Corporate Social Responsibility initiatives like the reduction of Carbon Emissions through operationalising Biomass Boiler, Roof Top Solar panels installation, and Heat pump commissioning.

• Leading the preparation and submission of Capex proposals for European regulatory market projects in India and overseas focusing on Injectables ,OSD, WH, Neutraceuticals—covering market forecasts, cash flow models, cost breakdowns, and timelines—while coordinating Corporate Office approvals and securing CMD sign off.

I have effectively led engineering teams to drive significant Capex projects and ensure compliance with industry standards. • Delivered multiple high-value projects, including a 5500 pallets ASRS project and formulation facilities for complex injectables. • Rolled out key initiatives such as Lean Six Sigma and predictive maintenance to enhance operational efficiency. • Developed technical skills through collaboration with IIT Gandhinagar faculty, establishing engineering and project academies.

Responsible to monitor & track Engg deliverables in terms of service uptime above 95% towards the plant consists of USFDA & EU approved 3 oncology Injectables blocks & one OSD block. Extending Technical support to other Geographical units located in Karnataka. Leading a Industrial 4.0 Enabled Digital Transformation Journey to achieve SMART FACTORY Status. Conceptualization & Road map for Energy optimization solutions, predictive maintenance of critical Assets through IOT| AI| ML | Data Analytics platform through reputed vendors in tune with Industry 4.0, Working on Concept of Total Autonomous Maintenance based on Japanese Concept Jishu-Hozen (JH), Pokayoke, Vertical Start Up , Kaizens etc. working on solutions for Engg QMS documents. Working on Brownfield & Greenfield capital projects costing approx. 150 Cr. to cater US/EU Regulatory markets through submission of Design concept, Cost & timelines Estimation , Risk Mitigation plan, Positive - Negative cashflows, ROI etc. it’s execution in Complex Injectables & Liposomes , Capacity Enhancement through Lyophiliser , compounding vessels , isolators etc. addition to enable for higher batch sizes etc. Continuous improvement projects by jotting down VSM ( Value Stream Mapping), DILO, DAIMC etc. through Lean Six Sigma concept, Utility expansion projects etc.

Leading Capital Projects of value 40 m$ across the project sites & also Driving Center of Excellence in Engineering with the Team of Experienced Working Professionals in Engineering to create a Benchmark across the Industry. Specifically working on Capacity Enhancement Capital Projects across different Geographical Manufacturing sites of OSD & Injectables & Derma, Contraceptives, High Pressure Homogeniser, Emulsion system, Microspheres etc. so as to meet the future market demand in compliance with USA & European Regulatory agencies. Spearheading Brownfield projects at site in terms of concept finalisation,URS, layouts, man & material flow, new equipment selection & Preparation & submission of Capex Proposals to senior management, conducting Project Cost & timelines assessment based on TOC, NPV, IRR etc. Involved in Techno commercial Negotiation with OEM’s, Design Consultants , Vendor’s in close coordination with Central SCM team As a part of Continuous improvement working closely with OEE & TPM team to improve OEE of the Mfg Sites by targeting Manager Model Area which is having high business value in the coming years under strict monitoring through Green Belt Lean Six Sigma Project initiatives. Working in depth to make Material Handling & packaging process more robust through ASRS & Track & Trace system implementation to have better control over this Final stage of the packaging before Material getting Despatched into the Market. Taken Proactive Energy Saving Initiatives at site by Generating Ideas with potential saving of more than 10 Cr across Manufacturing sites Driving Technical Capability Building Initiatives across the sites to make the sites Totally Autonomous in terms I-Operate, I-Maintain & I-Own Mantra.through Jishu Hozen & Keikaku Hozen Concept

Being a Cluster Head for Engineering Function at Duvvada, Vizag Cytotoxic OSD + Injectable and Advance Aseptic Formulation Tech Operations facilities (multiple facilities)leading a team of 50+ Engineers across the site. Worked very closely with International acclaimed Consultant McKinsey under Project SuCCEED to transform Quality Culture at site as a part of USFDA Remediation Action plan. Working with Renowned International consultants for world class maintenance(WCM), Total Productivity Mainenance (TPM), OEE implementation at site through Lean Six Sigma Green Belt Project Initiatives, leading PACE Energy saving initiatives at site . Monitoring & Tracking stringent timelines for execution at site, regular dealing with Factory inspector, pollution control board, DISCOM, boiler inspector etc. Recently undergone series of International audits of SA, TGA, USFDA, Germany, Taiwan etc. Successfully lead the team to achieve 100% Engineering compliance at site all the Time.

Lead a Team of Engineers during USFDA Inspection at LIFEPharma site in July 2017 and successfully cleared the Audit with ZERO Observations. Through this achievement LIFEpharma became the first company in UAE to get USFDA Approval. The Manufacturing Facility consists of Tablets, Capsules, Liquid Oral etc.With latest Technology Machines from Europe & South Korea & India and is approved by USFDA, EU-GMP, Health Canada Regulatory Inspection Bodies. Responsible for providing Engg.services towards the OSD plant & Cosmetic Plant too(Mfg.Wet Tissues, Liquid Soaps etc.) Ensuring 24 x 7 Compliance towards Safety and Quality through all time preparedness towards Safety and Quality Norms. Also responsible for Preparation, Review and submission of necessary Drawings, Documents to meet with Dubai Civil Defence, Civil Engg. Dept, Etisalat NOC, Dubai Electricity and Water Authority NOC, Dubai Municipality requirement. Having PINK CODE -3 Accreditation from Trakhees, Dubai (U.A.E) for to ensure Safety Compliance at site & represent my Site during Operation Fitness Certificate Audit every year to ensure Compliance. Taken initiative in rolling out SAP-R3 Module which includes Breakdown orders, Preventive Maintenance Orders, Calibration module, Engg,change Management, Deviation and Incident Management etc. Heading Entire Greenfield Project activities of Oncology Inject able and Oral solid dosage (Tablet & Capsule) formulation facility at KIZAD, Abudhabi in terms of following project activities: Preparation & review of Concept, preliminary and Detailed design of the facility in coordination with International Consultants IPS, India .Review Tenders, Bids, Techno commercial comparison & seek approval from Sr.Management for the procurement. Define and update Project timeline and Cost Schedule to the Sr.Management. Technical Interaction with the stakeholders and Conclude the Meeting outcome and Execute toe project work at site.

With recent Merging & Acquisition now Globally our Organisation Watson will be recognised as Allergan now on wards. Working on Multiple projects of different sites at Europe & Goa like : 1. Cyto & Non Cyto Injectables at Nerviano, Italy 2. Inhalers (MDI & DPI ) @ Ireland 3. Recently successfully Executed HVAC project for DPI facility at Istanbul,Turkey successfully(Onsite) 4. PDL lab HVAC project for High containment Facility @ Goa Work Exposure : Hands on Experience in dealing with : 1) International Consultants like Jacobs(Europe), IPS(USA & India) 2) Imported Equipment suppliers like DH Industries(UK), Diosna(Germany), HH(Germany), B+S (Germany) etc. 3) Industry experts, Regulatory experts, R&D team & QA team etc. Key Deliverables : a) Preparation of Concept document, URS, Layouts etc. b) Preparation of Request for Provision(RFP), Scope of Work (SOW), Business case with c) Engg.costing & detailing, Project Time schedule with milestones etc. d) Leading the team of Experts in core areas e) Technical review of Capex Projects Proposal across different sites at Europe & Asia f) Extending technical support in executing different energy saving projects across the sites. g) Technical Review of URS, Capital Budget Requests for Formulation facility Expansion Project and to provide Value added recommendations for the Organisation. h) Technical Interaction with Design Consultants for Facility, Masterplanning experts, Equipment Suppliers, Subject Matter experts etc. i) TO prepare and present Different Layout options for Man/mat flow, area classification, Pressure Diffrentials, Location of key equipments, Waste Disposal etc. to the Sr.Management Team j) To Interact, Review Technical proposals of the Latest Technology Equipment & Systems & explain to the Sr.Management team & seek their consent k) To do the Engg.detailing for utility High side, low side & corresponding Costing l) Present Technical proposals to the Sr.Managment

Key Responsibilities: Challenged to handle the entire gamut of activities related to Engineering detailing & costing for Execution of Formulation Projects across: 1) Oncology solid Oral Dosage & Injectables 2) Advanced Aseptic Formulation facility which will comply with USFDA/EU Guidelines. Build and lead a team of 40 young Engineering professionals & achieved Best Work team award across the Organisation under the team name "KAIZEN"​ & "STRIKER". Diverse projects activities involved in: Conceptual, Preliminary and detailed design of the facility, Equipment and systems Technical comparison of equipments for Manufacturing & Utility. Working out of total costing of Entire Project and its submission to the Management Technical detailing, HVAC conceptual design, calculations, Execution and extend support during Qualification for the same. Involvement in the erection & commissioning, Qualification, Maintenance & Troubleshooting of all Process equipments like Lyophiliser(Martin Christ), Moist Heat Steriliser & Terminal Steriliser(Fedegari), B+S Vial filling line, Steriline Make positive pressure Isolators, SKAN Make Glove Integrity testing machine etc. PLC programming / troubleshooting, Instrumentation P& ID review, Fish Bone analysis, Quality and Safety Incident Investigation Hands on Experience in successful implementation of ASTM-2500 at project stage. Involved in the following areas : Conducting QRAE, URS preparation for process equipments and utility systems Identifying CQA and CPP for the same. Preparation of Verification Master plan and test plan(VMP & VTP) Preparation of Requirement Tracability Matrix Engineering Change Management, Descripancy Management, CAPA, Impact Assessment, Safety & Quality Incident Investigation. Hands on Experience in interacting with International Auditors of USFDA, Germany, Brazil & also Customer Audits from GSK, Merck, Mitsubishi etc. and successfully achieved Regulatory certificates after project Completion

Heading Engineering services Team of Young professionals to comply Safety & Quality Requirement at plant. Closely worked with Central Capex Project team & OEM Engineers from Germany & Italy during Remediation Projects at Oncology Injectables & OSD facility of Fto7 to comply USFDA observations Actively involved during Successful International Regulatory Audits of Germany, Brazil & USFDA Worked very closely with Renowned Industrial Experts in Injectables from USA & Europe during Remediation project

Handled Key formulations Projects on Oncology, Inhaler , Ophthalmic & Nasal Spray . Key Deliverables : Preparation of concept, Preparation of simple plan layouts,Area classification layouts,Pressure diffrential layout ,Equipment layout ,AHU zoning layout preparation of Engineering detailing & costing Interaction with International Consultants ,Equipment suppliers & experts for Imported machines Preparation Business case & submission to the Management for Capex approval

A reputed 100 % EOU Unit & USFDA & MHRA approved plant, reporting to Vice-President (Operations) Regulatory Approval for Unit-3 Formulation Plant: Successfully faced & lead Entire Engg.Team in achieving MHRA-UK Approval for Formulation Mfg. Block at Unit 3 conducted by Auditors Mr.Jeckson & Mr.Michel Oliver. Key Responsibilities: Charged with a team of 25 Technical people comprising of Technical Staff/Technicians, looking after Four Formulation Blocks-Engg. Activities & also the utility for the same & handling on going Block Expansion Project. Installation & commissioning of Compression, coating, Granulation machines & corresponding HVAC System for the same. Ensured smooth coordination with the vendors for HVAC Layouts, datasheets, URS & machines & equipments.

Secured First class in BE ( year 1990)