Devendra Palav Email & Phone Number

Mumbai, Mh, In

Mumbai, Maharashtra, India

- Managing multiple manufacturing sites and setting up new manufacturing site- Reporting function – CMO Management, Purchase, Planning and Scheduling, EHS, Operational Excellence, Tech transfer dept, Project Management, Sourcing, People in Plant - Supplier Performance & Third-Party Oversight (TPO)- of 22 different locations across India - Review & Governance for Performance & Quality Management System for the function - Relationship management with CMO- Audits Management –… Show more - Managing multiple manufacturing sites and setting up new manufacturing site- Reporting function – CMO Management, Purchase, Planning and Scheduling, EHS, Operational Excellence, Tech transfer dept, Project Management, Sourcing, People in Plant - Supplier Performance & Third-Party Oversight (TPO)- of 22 different locations across India - Review & Governance for Performance & Quality Management System for the function - Relationship management with CMO- Audits Management – Quality, Business & EHS audits - Responsible for key KPI’s – Safety EHS, Quality, Service, Financials- Compliance of external supply network wrt to Anti Bribery Anti-Corruption & Legal Contracts- Member of ES governance / Quality council. Risk Management Board & Tech Transfer Governance Board- Identification and selection of new contract manufacturing sites, Due Diligence process- CMO consolidation, product portfolio analysis, Risk management, ICF (Internal Control Framework)- Long term capacity planning and strategic decisions pertaining to capacity, identification of bottlenecks/constraints in capacity and technology - Finalization of conversion cost, traded product cost negotiation - Identify cost saving opportunities though Op Excellence mechanism - define project milestones & timelines, drive & deliver- To support supplier Quality agreements- To develop best in class CMO’s through culture of continuous improvement & GSK production System- Sustainability at CMOs – Water, Energy, Waste and Plastic Waste Management- Instrumental in developing new manufacturing site Show less

Pithampur ,Mumbai, Usa

- Project and Production startup activities at Glenmark – Pithampur - Setting new manufacturing facility, Entrusted job of technical transfers of products from development centerMajor Accountabilities: - Manage technical transfers of ANDA/EU Exhibit batches & site to site transfers. - Manage expansion project assuring optimal cost, timelines, functionality & quality.- Facilitate Production operation management leveraging resources, systems and processes to deliver… Show more - Project and Production startup activities at Glenmark – Pithampur - Setting new manufacturing facility, Entrusted job of technical transfers of products from development centerMajor Accountabilities: - Manage technical transfers of ANDA/EU Exhibit batches & site to site transfers. - Manage expansion project assuring optimal cost, timelines, functionality & quality.- Facilitate Production operation management leveraging resources, systems and processes to deliver the FDF of required quality & within timelines.- Recruit & train people for high level of performance, align them to organizational goals & objectives.- Identify & apply new processes & technologies during building new facility.- Management of GMP, HSE & issues related Manufacturing- All time readiness for important audits viz. USFDA, MHRA - Outsourcing of finished formulations from various LL, manufacturing locations across India for domestic markets.- Launch management of new products for EU/US markets.- Technical transfers of new products at LL units - To set up operational excellence department and initiate and successfully run the relevant projects- Implementation of advanced planning & sequencing software (JDA). - Identification and selection of contract manufacturing sites and creation of supply chain network in USA. In year 2014. Instrumental in setting new plant in USA. Show less

Navi Mumbai

As Designation – Project Manager Building a global OSD manufacturing plant (capacity of 6.0 bio units per annum) for regulated market from initial conceptualization phase to commercial production. - Functioned as a Project Manager for phase I project for oral Solid Dosage forms.- Production team Member for Cephalosporin based finished dosage formulation project at Turbhe New Mumbai - Functioned as a Core Team Member for Sandoz SAP Implementation & Project Manager for… Show more As Designation – Project Manager Building a global OSD manufacturing plant (capacity of 6.0 bio units per annum) for regulated market from initial conceptualization phase to commercial production. - Functioned as a Project Manager for phase I project for oral Solid Dosage forms.- Production team Member for Cephalosporin based finished dosage formulation project at Turbhe New Mumbai - Functioned as a Core Team Member for Sandoz SAP Implementation & Project Manager for Novartis India SAP implementation.- Lead the Production Team for various regulatory audits viz. USFDA, EU, ANVISA, Japan PMDA, TGA, KFDA and Novartis Global quality audits.- Inducted in various Sandoz plants across the globe - EU, US & Japan.As Head Operation (Production, warehousing & Tech Transfer)Significantly contributed in:- Production Management for reliable supplies of products for highly regulated markets viz. US, EU & Japan.- Manufacturing FDFs in total compliance with internal guidelines & external regulatory requirements.- Training & development of associates in Production. - Resolution of technical issues with internal & external partners.- Involved in overseeing the activities pertaining to Project & Change Management.- Holds the credit of identifying & applying the process technology to support manufacturing strategy for development /site to site transfers & launches.- Monitored the functional performance of subordinate & teams.- Oversaw the manufacturing and technical transfer of products for regulated market from Global development centers and overseas plant.- Served as a key person for recruitment & building of entire production team.As Production Manager - Produce Quality products to comply Local, International & Group norms , Regulatory & GMP aspects at a competitive cost- Ensure manufacturing and timely supply to the customer to meet Launches, avoid stock outs Show less

Mumbai Area, India

- Served as the Head of Contract Manufacturing& Loan licensing Cell - Responsible for finished product rate negotiation & purchasing of around 170 SKU’s (~250 crore) from various third parties locations across India, also including LL activities- Instrumental in building Quality Generics department - Responsible for setting up of systems and controlling a staff of 21 employees stationed at various LL/TP locations across India.- Led the technical transfers of products… Show more - Served as the Head of Contract Manufacturing& Loan licensing Cell - Responsible for finished product rate negotiation & purchasing of around 170 SKU’s (~250 crore) from various third parties locations across India, also including LL activities- Instrumental in building Quality Generics department - Responsible for setting up of systems and controlling a staff of 21 employees stationed at various LL/TP locations across India.- Led the technical transfers of products from In-house manufacturing facilities to contract sites & tax saving zones - Commended by Managing Director for rationalization of packing / raw material suppliers & renegotiation of rates with Third Parties to achieve the significant cost savings.- Encouraged & backed the selected units for GMP improvements & WHO-GMP approvals.- Designed Third party manual covering SOP’s for important procedures.- Managed the Rating & Reward System for third parties leading to quality & cost competitiveness Show less

Navi Mumbai

Heading Sterile , Semi Solid sections

Navi Mumbai

Injectable Manufacturing, Packaging