• Gender: Male
• Age: 51
• Designation: Manager QA/ RA
• Highest Education Level: Graduate - Degree
• Preferred Country: India
• Preferred Location: Haryana
• Work Experience: 29 Year(s)

Education

B.Sc. (PCM) from M.D.University Rohtak (Haryana) in 1995.
PG Diploma in Quality from ALL India Institute of Management Studies Madras in 2000.
M.Sc. (TQM) from Kuvempu University, Karnatak in 2009.
FDA approved for Manufacturing of Medical devices from Gujarat on Form-28 was valid till Feb 2017.

Skill Sets

Ability to perform the process and achieve the target .
Demonstrated ability to communicate effectively in a team environment.
Good documentation/Computer Skills.
Developed, adopted and maintained Quality systems in the working Area.

Work Experience

Manager QA/RA
From -May-2021 to till date
Company profile - The company is manufacturing of Disposable syringe, I.V. Set, B.T. Set & Extension tube.

Production Manager
From -Aug-2015 to Jan-21.
Company profile -The company is manufacturing of Disposable syringe, Re-use prevention/AD Syringe, I.V. Set, B.T. Set.

Job profile -
Development of raw material like as Printed paper/Laminate, film, Inner Boxes & Master Carton as per Our Product requirement and Std.
Evaluation of defects as per requirement with quality plan and take CAPA if any deficiency.
Monitoring of product productivity and quality on Injection Moulding component, Printing, Assembly, Packing and box packing stage.
Monitoring of product productivity and quality on Final stage as per FDA requirement, ISO, CE & MDD. For Export Material Inspection as per customer requirement, ISO, CE & MDD. For Export Material Inspection as per customer
Take part the development of packing material like as Laminate/film, Box and ocarton as per Export/customer requirement.
Control of Non-conform material and its Disposition. Take corrective and preventive action for defects occur in working Area.
Handling of Market complaint and take needful action.
Developed and implement Process control Like as Histogram and FTQ to control Rejection and increase Production.
Training given to Junior to Operate Instrument Like as Injection moulding (L &T), Printing machine, Syringe Assembly Make Korea, Sterilizer, Penetration test M/c, Bond Test and Aspiration test/Leakage test, Tensile Strength Tester, salt spray tester, Rubbing & fastness of colour, Viscosity test, Flow rate tester, MFI tester, Gram mage , stability study and Bursting strength Tester.

Preparation of plan layout, SOPs as per FDA/ ISO and CE, section/stage wise respective requirement on time to time.
Developed, adopted and maintained quality systems in the Production area (Injection Moulding, Printing, Assembly and Packing), laboratory Area as per ISO, CE , GMP and FDA.
Planning of production in respective stage as per machine productivity and order.
Data collection as per project requirement like- number of machines (Injection moulding, Packing and sterilizer) , cost of machine, details of mould as per syringe component.
Implement 5-S , POKA-YOKA, JIT, FIFO activities for prepared a well discipline environment, culture of quality and respects for human value.
Ability to learn New techniques quickly, work independently commitment to quality, excellent inter personal and communication skills.
Very Open to any idea to work on and very determined to complete the jobs on time..
Experience in calibration, qualification and preventive maintenance of critical equipment like (microbiological section) Autoclave, Hot air Oven, BOD Incubator, colony counter, centrifuge. Take parting calibration, qualification and Maintenance of ETO Sterilizer and other m/c lying in Deptt.
Maintenance and procurement of reference standards, working standards and laboratory regents and tool related to machines.
Monitor cleaning of the manufacturing facility during product change over in working area (Clean room).
Review updating and preparation of various documents i.e. SOPs, Log Books, Validation, and Calibration, Monitoring, Cleaning, Stability and STP documents as per GMP/Drugs requirement.
Participate in external Audit preparation of documents which are required in like- FDA (Indian) & ISO-9001:2008, 13485:2012, CE and conduct internal audit. I can also handle FDA regulatory work as per india FDA, KEMSA and NAFDAC.

Production Mgr
From - Sep-2014 to Jun -2015
M/s Revital Healtcare EPZ Ltd.,