Medical Manager

CURRICULUM VITAE

RAJENDRA KUMAR GUPTA

Production Head

Company website: www.inventbio-med.com

Mobile: 91-989******* / 972-***-****

E-Mail: **********@*****.***

Senior assignments in the field of overall Production/Operations & Maintenance activities with leading Healthcare/Medical Devices, Plastic/Mechanical Engineering Organisations.

PROFESSIONAL OVERVIEW

A seasoned professional with over 25 years of rich experience in Manufacturing / Production Management Operations & Maintenance and Erection / Commissioning in Medical Devices Plant.

Presently associated with Invent Bio-Med Pvt. Ltd. Surat (Gujarat) as a Production Head.

Approved Manufacturing Chemist - Approved From FDA – MADHYA PRADESH.

6-SIGMA Green Belt.

Certified Internal Auditor by SGS.

Gained adequate knowledge on hydraulics & pneumatics, parts and product quality, problem solving techniques, quality system establishment and quality of supplier parts. Proven abilities in managing technically advanced, cost-efficient systems and processes. An effective communicator with skills in managing & training the workforce and updating them as per the latest industry trends & technicalities.

To schedule the production on weekly basis, as and when required, on the availability of the material.

To handle the all Man, Machines, Materials and Process related problem.

To complete the all Production on time with Good Quality and minimum Rejection.

To execute the production schedule and co-ordination with respective section Heads.

To control the all sections as for maintaining the smooth functioning in different sections.

To take periodical rounds of all the sections & to ensure that production takes place as per GMP Guidelines.

To guide the all Production Operators, Technicians, Supervisors, shift in-charge & Section in-charge in case of any problems or issues.

To correct the people by training who are violating GMP or who are working ineffectively. To trouble shoot any technical problems or equipment problems.

To ensure the well maintenance and up keeping of the production premises.

To ensure the proper recording of all functions.

Performing the review, verification & validation process as per plans.

Total Industrial Experience:

I have more than 25 years of rich experience in Medical Devices industries with clean room activities.

1)Work experience with Invent Bio-Med Pvt. Ltd. Sachin, Surat (Gujarat)

Presently I am working in this company as “Production Head” from August 2017 to present.

Invent Bio-Med Pvt. Ltd. is a leading, fast growing and a professionally managed Medical, Healthcare Devices (Angioplasty & Angiography Kits) company in India. Company having class 100,000, 10,000 and 100 clean room.

Overseeing all activities from Raw Material Purchasing to Finish Good except Admin and QA/QC.

Its product is Angiography and Angioplasty Kits, 2 port/ 3port Manifold, Stent & Balloon (Invento, Nano-chrom and Nova Vida Chrome), Y-Connector, Inflation Device, Angiography Guide wire, Introducer Sheath etc.

2)Work experience with Phoenix Innovative Healthcare Manufacturers Pvt. Ltd., Navi Mumbai

I was working in this company as Manager Production (Plastics and Wet division) from September 2014 to August 2017.

Phoenix Innovative Healthcare Manufacturers Pvt. Ltd., is a leading, fast growing manufacturing and a professionally managed Medical & Healthcare Devices company in International Market Headquarter in USA (Florida) based MNC Company being a class 100,000 clean room.

I was handling more than 300 Man Power.

Its product is Lancing Devices, Blood Lancet, Safety Lancet, Alcohol Prep Pad, Swabsticks etc.

Very good knowledge in ETO and Gamma sterilisation.

Maintaining documents as per FDA and ISO requirements.

Faced a lot of internal and external and customer audits as per medical device industries requirements.

Planning for production for smooth run.

Taking preventive actions periodically to avoid breakdown.

Ensure of IQMS inventory.

Manpower selection and giving training to all manpower regarding all production activities.

Very good knowledge in Plastic injection moulds & machines, pad printing, sealing and packing machine and foil printing.

3)Work experience with Albert David Ltd., Mandideep (Bhopal) as a Deputy Manager (Production & Maintenance) from Apr’ 2006 to Aug’ 2014

Albert David Ltd. is a leading, fast growing and a professionally managed Medical Devices

(Disposable Syringes & Needles) company in India.

Managed all Production activities of Disposable Syringes and Needles manufacturing plant as per ISO 9001: 2008, ISO 13485: 2003, and CE Marks.

4)Work experience with Hindustan Syringes & Medical Devices Ltd., Faridabad as an Engineer (Production) from Nov’ 1992 to Apr’2006

Hindustan Syringes & Medical Devices Ltd. (HMD) is Asia’s largest Syringe manufacturing company. HMD’s standard disposable syringe "DISPOVAN" is the only established brand name in the syringe market in India. The company manufactures over 1.2 Billion syringes per annum at its multiple manufacturing locations in Ballabgarh (Haryana).

Managed all Production activities of Glass Syringes and Cannula/ Needles plant as per ISO 9001: 2008, ISO 13485: 2003, and CE Marks.

Key Deliverables:

Production Management

Managing activities right from the conceptualisation stage to the execution; involving finalisation of technical specifications, procurement, scheduling, progress monitoring, erection, testing & commissioning, site management and manpower planning.

Handling activities involving working out various requirements & monitoring overall project operations for ensuring timely completion.

Maintaining satisfactory working conditions, cleanliness, safety, etc. through knowledge of first aid, fire prevention & fire fighting techniques.

Operation Handling:- Production & Maintenance of Horizontal & Vertical Injection Moulding M/Cs, Blood Lancet, Lancing Device, Bullseye Safety Lancet, Two part Disposable Syringes Moulds and multi cavity moulds, CNC Cylindrical Grinding machines, Taping machine, Electrolysing, Ultrasonic Cleaning, A.H.U., Air Compressor, Utility Services, Ultrasonic Welding, Printing, Alcohol Prep Pad Manufacturing Machine, IPA Mixing Plant, Solution Preparation, Drug Coating, Crimping, Assembly & Packaging and Sterilization etc.

Monitoring the activity at sites and reviewing of project schedule, ensuring cost control within budget, planning for cash flow requirements, etc.

Maintenance / Operations Management

Planning and effecting predictive & preventive maintenance schedules for various equipment’s to increase machine up time & equipment reliability.

Implementing maintenance schedules and carrying out periodic checks to ensure performance of various equipment and maintaining requisite documents for the same.

Overseeing the functioning of the coolant treatment (cutting oil), glass beads according to gauge size.

Maintaining records as per standards ISO 9001: 2008, ISO 13485: 2016, CE Certification & Certificate of Pharmaceuticals Product under cGMP Certification scheme.

Responsible for manpower handling, assigning daily jobs to company Engineers, technicians, and operators.

Proactively identifying areas of obstruction / breakdowns and taking steps to rectify the equipment’s through application of troubleshooting tools.

Vendor Development

Actively participated in vendor development for Injection Moulding Machine, Two part Disposable Syringes Moulds, CNC Cylindrical Grinding Machine operational vendors

Cost reduction activities handled for machine parts sourcing.

Proactively identifying new technology / product features.

CNC Machine Operations / Programming

Initiating the programming of the CNC machines to facilitate ease in design for manufacture and reliably measure the quality of CNC programmes.

Executing CNC programming in Fanuc, Simpo and Siemens controllers.

Maintaining high productivity in various machines in line, troubleshooting problems and bottlenecks to facilitate seamless flow of operations.

Focussing on spotting and rectifying programming errors so as to increase efficiency and profitability and reduce the incidence of scrap.

Erection & Commissioning

Handling erection & commissioning of the heavy equipment’s as well as conducting tests & inspections to ensure operational effectiveness of plant & utilities.

Reviewing engineering drawings, layouts, diagrams, technical specifications, cost estimates for erection & commission of the plant.

Carrying out erection and commissioning of the following:

CNC Cylindrical Grinding Machine Make: Saito Medical Industries Ltd., Japan. Control System: FANUC (LP-700) DIASON SIMPO (NC-MICRO).

Taping Machine: Make Satio Medical Industries Ltd., Japan.

Cannula Cutting Machine Make: Nihon Disk Ind. Co. Ltd., Japan.

Automatic Brushing MIC PLC- Controlled.

Injection Moulding Machine Make: Feromatic Milacron INDIA, Jet Master China, L & T / Toshiba & Electronica.

Ultrasonic Welding Machines.

Notable Highlights:

Visited M/s. Saito Medical industries Inc. Japan during January 2008 for the Pre-Dispatch Inspection and Trial Run of ordered CNC Cylindrical Grinding Machine.

Increased output from reducing cycle time from 35 Second to 32.60 Second in Vertical Moulding Machine for Blood Lancet Production.

Actively participated in manpower reduction through implementation in cycle time and conducting trainings over critical machine operations.

Implemented recycling processes with the cost reduction projects, such as glass bead weight reduced from 25 kg/day to 12 kg/day.

Actively participated in training programmes for reduction in machine operational defects with operators, technicians and Engineers.

Compiling failure data and imparting training on key area for continual improvement in product quality.

Effectively handled vendor development activities, as per company standards.

Supported Quality system requirements including ISO 9001:2008, ISO-13485, CE-MARK, quality certifications.

Appreciated for best 5 S activities implementation at shop floor.

ACADEMIC CREDENTIALS

Diploma in Mechanical Engineering from U.P. Technical Board, Lucknow, in 1992; 1st Division.

PERSONAL DETAILS

Date of Birth : 21st October 1970

Languages Known : English & Hindi

Permanent Address : H. No. 44, Ideal Campus, Near Indus Town,

Hoshangabad Road, Bhopal - 462047, (M.P.), India

Current CTC : 10.00 Lacks per Annum.

Expected salary : Negotiable

Notice period : 30 Days (Negotiable)

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