MEdical Device Domain

MANJRAMKAR GAJANAN PRABHAKAR.

Row House No – E-*, Khinvasara Nilgiris,

Plot No -3 ,Khinvasara Park [East] ,Garkheda.

Aurangabad - 431005, Maharashtra.

Phone: 91-240-******* (R), 982-***-**** (M)

E-mail: ********@**********.***

Job Objective

Senior level assignments in overall management of operations in Plastic Injection Moulding / Medical Devices sector. Subject Expert in Medical Devices & Plastics.

Summary of Skills & Experience

 Over 15.5 years of experience in overall management of operations (Plastic Injection Moulding) & Health Care products and medical devices.

 Complete familiar with Medical devices product like Blood Lancet, Disposable devices, Syringe Needles , Urine Drainage Bags, & Foley Catheter.

 Worked in Plastic Medical Devices operations for 14 years.

 Worked Under world leaders in Medical devices i.e. Mearsk Medical – DK for 4 years under JV with TTK India.

 Core competence in Production, planning & control, process reengineering, operation & maintenance, procurement and vendor development.

 Expertise in Plastic Injection moulding for developing new products and ensuring smooth operations of injection moulding units. [machines & moulds. ]

 Experienced in process re-engineering, standardizing production norms & developing new process parameters for optimizing resource utilization & productivity improvement.

 Experienced in execution of projects dealing with product development and developing the related injection moulds, tools and jigs & fixtures.

 Well conversant with the applicable FDA, GMP, ISO standards for production of medical devices and hands on experience in implementing the said standards.

 Post Graduate Diploma in Production Management Division from Marathwada University and Post Graduate Diploma in Plastic Processing and Technology with distinction from CIPET Hyderabad.

 Complete familiar with Ethylene oxide gas sterilization process with half cycle validation and process detection for various products & packing style of medical devices.

 Experienced in complete manufacturing to finished product process of medical devices like Foley Catheter, Urine drainage Bag, Blood Lancet, Disposable syringe & needles with Blood collection system (Blood Bag).IV Fluids.

 Experienced in implementing & maintaining ISO & EMS system with Environmental aspects.

 Crossed worldwide standard limit and achieved highest Yield for Foley Catheter process.

 Key performance are is GMP, Clean Room & sterilization.

 Worked as a ISO internal quality auditor.

Key Areas of Expertise

Production Planning and Control

 Effective planning and scheduling to meet pre set production targets and maximize production with minimum work in process inventory levels.

 Designing internal controls for various operational areas and verification of operational efficiency levels & recommending cost control measures.

 Planning & scheduling effective preventive/ predictive maintenance to enhance equipment reliability and productivity.

 Good inter personal skill for managing operations. (Total 160 workmen & Staff reporting)

Operation & Maintenance

 Ensuring smooth operations to maximise production and to meet pre-set production targets.

 Planning & implementing effective preventive & corrective maintenance schedule to enhance equipment reliability.

Process Improvement

 Conceptualizing and implementing modifications in the operating procedures to optimize resource utilization and maximize productivity.

 Implementing cost reduction projects, GMP (good manufacturing practices) to enhance profitability and productivity.

 Development of Blood Lancet tool & dies.

 Development of process and other transparent formats/reports for continuous improvement & management information.

Project Management

 End to end execution of projects for developing new products and setting up the manufacturing facilities and implementing innovative concepts for process improvement.

Materials Management

 Effective materials management and inventory control to maintain smooth flow of materials for production with minimum inventory holding.

 Identifying and developing alternate vendor source for achieving cost-effective purchases of raw materials and out source low value added products.

 Oversee adherence to quality standards and consistency in material quality.

Quality Control

 Ensuring complete in-process quality control and continuous improvement in process capabilities.

 Implementing QMS, EMS and ISO 9001-2000 & 14001 norms and ensuring adherence to them as internal auditor.

 Attended Seminar at Cochin for 510 K [UK] Standards.

 Attended & successfully completed the workshop on ISO Internal Audit.

Human Resource Development

 Developing, managing and monitoring the performance of multi-skilled work force and conceptualizing need-based training programs

Organizational Experience

1] Since Nov 2008 with TaTa Consultancy Services Pune as associate consultant for Manufacturing domain.

- Presently working in medical device domain.

2] From Nov 2005 to Nov 2008 with Vaidya Group of Industeies , Aurangabad as corporate Dy. General Manager-

- Over All responsibility of 4 injection moulding business units.

- Responsible for Production,QC, commercial & technical matters.

- Reporting to CEO/CMD.. Responsible for product & system development.

- In charge of overall activities of the units.

- To achieve desired operating profit from the unit.

- Implementation of new projects and capital investment.

- New product development and technical support to business development team for new business.

- Approval of vender through technical & commercial assessment.

- To build organization with competent / motivated employees.

- To lead the organization for achieving vision and mission

- To protect environment and ensure implementation of Quality and Environmental Policy within the unit.

- To ensure proper customer service

- To keep transparency in the overall working of the unit.

- Employee performance feedback through job profile / KRA & performance bonus.

- To ensure compliance to Statutory requirements.

- Liasoning with Govt officers and external agencies

- Manufacturing management for the fabricated activities for the zone.

From October 2001 to Oct 2005 with TTK Health Care Ltd. (TTK Group, India) Aurangabad as Manager- Production & Engineering

Key Tasks Handled

 Successfully handled production of medical devices viz., Foley Catheter, Urine Drainage Bags, Blood Lancet, and ETO Sterilization among others.

 Ensured smooth operations of injection moulding machines viz., Klockner Windsor, Mafatlal Nigata, PVC Extrusion machine Klockner Windsor to meet production targets.

 Successfully implemented process modifications and measures for optimizing resource utilization and achieved 10% increase in productivity and effective cost savings.

 Executed product development projects and developed products viz., ‘Urine drainage bag’ with top out.

 Handled the additional responsibility of the Engineering Department and established system of preventive maintenance tools, dies & moulds and achieved substantial savings through effective maintenance.

 Successfully implemented ISO 14001 standards and handled the relevant documentation and formalities for securing the ISO 140001 certification.

 Liaisoned with various government bodies and agencies viz., MPCB, MSEB to ensure compliance with statutory requirements.

 Played a key role in securing FDA (Maharashtra) approval for ‘Medical Device Production’ and ‘Sterile Suture Manufacturing’.

From October 1996 to September 2001 with TTK Maersk Medical Ltd. Aurangabad as Manager Production and Tooling

Key Tasks Handled

 Successfully handled the production operations for the production of Foley Catheter, Urine Drainage Bags, Blood Lancet.

 Played a key role in implementing GMP (good manufacturing practices) ISO 9001-2000 & ISO 14001 standards.

 Successfully executed the technology transfer project from Maersk medical Malaysia for setting up the Foley Catheter Plant and successfully implemented the modern technologies & safety standard.

 Played a Key role in technology transfer and visited to EUROMEDICAL - Sungai Pettani & Maersk Medical – Kulim Of MALAYSIA for streamlining the Foley Catheter process in India. Visited Malaysia 4 times for Technology Transfer.

 Ensured adherence to FDA & ISO regulations and quality standards

From January 1994 to September.1996 with TTK Biomed Ltd Aurangabad as Production Sr. Executive

Key Tasks Handled

 Independently handled the overall responsibility of Injection Moulding Department and Syringe & Needle Plant for production of 3 million Disposable Syringes & Needles per month.

From November.1992 to December.1993 with Lorcom Protectives Ltd., Aurangabad as Production Assistant

Key Tasks Handled

 Gained hands o experience in injection moulding for production of Lorcom Protectives Ltd.

 Started carrier in Medical devices i.e. Syringe & Needle.

 Worked in projects.

 Well adjacent with FDA,GPM Norms.

Educational Qualifications

 Post Graduate Diploma in Production Management Division from Marathwada University in 1994.

 Certificate course of computer basics & window based operating systems.

 Post Graduate Diploma in Plastic Processing and Technology with distinction from CIPET Hyderabad, in 1992.

 Graduate in Science (Chem & Phy) from Marathwada University in 1990.

Date of Birth: July 19, 1971.

Present Salary : 11 lacks p.a.

Contact this candidate