Ashwini Ghangale Email & Phone Number

Belrose, New South Wales, Australia

Sydney, New South Wales, Australia

Sydney, New South Wales, Australia

Belrose, New South Wales, Australia

Sydney, New South Wales, Australia

Navi Mumbai

• Participation in new product introductions including BOM and routing changes• Develop, maintain and review the current contract manufacturing strategy and partnerships across India.• Lead, collaborate with internal cross-functional teams (PD/TCS/Supply Chain/Quality/SHE/Engineering)Implement new projects, determine manufacturing requirements. • Drive contract manufacturer capability and capacity evaluation to enable on-time delivery of project and products going forward.• Manage schedule, capacity, supply chain flexibility, quality issues and new product updates. • Communicate status and risks to management. • Maintains work flow by monitoring steps of the process; setting processing variables; observing control points and equipment; monitoring personnel and resources; studying methods; implementing cost reductions; developing reporting procedures and systems; facilitating corrections to malfunctions within process control points; initiating and fostering a spirit of cooperation within and between departments.• Negotiate master service agreements and SLA, KPI, Pricing.• Lead meetings to ensure new product development and cost saving initiatives.• Strong spreadsheet and numerical analysis skills Knowledge of SHE / QA/Compliance/Manufacturing processes Problem solving, self-starter Maintains quality standards, establishing and enforcing Henkel standards.• Ensures and maintains safe and clean work environment by educating partners and directing personnel (if any) on the use of all control points, equipment, and resources; ensuring compliance with established policies and procedures.• Measure partner performance and drive continuous improvement with regular business reviews. Identify and champion process improvements in support of new contract manufacturing requirements.

Mumbai, Maharashtra

Production Plan Execution to TP / LL as per Prod. Capacity for all dosage forms i.e Solid,Liquid,Sterile & ointments. Handling entire process starting from Forecasting, material planning, ordering follows up, Follow-up for timely deliveries of the product & providing monthly report for on time delivery performance (OTIF), Arrange cross functional meeting with supplier to improve the delivery performance service level other KPI. Can handle PP module of SAP. Updating daily dispatches via SAP ,STO preparation & to solve OBD troubleshooting, follow up for the created PR & chasing of new product launching in existing & new LL & third party contract manufacturing sites. Lead a project to launch of new product as well as to start manufacturing of technology transfer products. Responsible for: Achieving production as per monthly production plan with quality aspect. Launching of new R & D products at L.L.  Handling & solving troubleshooting regarding quality of product and coordinating with QC, QA & R&D departments.  Knowledge of cGMP, Quality Systems and the pharmaceutical TPO( Third Part Operation ) & LL manufacturing. Follow up with Sourcing, Regulatory, SCM members providing/performing quality inputs/activities in the selection process for any new supplier.  Attend & organise Quality and Business Review Meetings as required.  Updating Weekly OTIF(Schedule OTIF & Plan Vs actual OTIF), Stock out list,Preparation of MIS on monthly and weekly basis. Chasing for critical products & escalation of issues to management pertaining to launching of the products & technology transfer products.. Trending and reporting data in monthly compliance reports. KPI and Quality improvement plan monitoring.. Provides training to the new employees .

Navi Mumbai, Maharashtra

Job Description :  Production of Plasma proteins :• Supervising routine production activities on the shop floor using manual control methods.• Monitoring the process using automated PCS7 HMI digital control system. Documentation :• Development, reviewing & implementation of SOPs for various processes on shop floor in co-ordination with QA & production.• Reviewing & maintaining BMRs generated daily by production & quality teams.  Management (via SAP) :• Controlling inventory flow in the shop floor.• Monitoring the consumption of raw materials per batch of production on daily basis.• Generating indents/PO for all materials & equipments in time for purchase team to procure the same & ensure uninterrupted production plans.  Process related :• Conducting FAT (Factory Acceptance Test) for all new equipments & machinery on shop floor. • Performing CTP (Commissioning Test Protocol), DQ (Design Qualification), IQ (Installation Qualification), OQ (Operational Qualification) & PQ (Process Qualification) for the above equipments.• Conducting validation of all processes & equipments.• Performing water trials for the validated equipments & processes.• Reporting all deviations & regularities for process standardization. List of equipments handled with dexterity :• PCS7 HMI digital control system • Ion Exchange Chromatograph • Tangential Flow Filter • CIP (Cleaning In Place) unit