• Gender: Male
• Age: 57
• Designation: Manager
• Highest Education Level: Post Graduate Diploma
• Preferred Country: India
• Preferred Location: Anywhere
• Work Experience: 35.3 Year(s)

Education

M.B.A (HR) Indira Gandhi National Open University in 2006
P.G. Diploma in Business Management Osmania University 2003
Diploma in Quality Management National centre for quality Management in 1998
B.Sc . (Chemistry) from University of Madras in 1988

Computer Knowledge
MS OFFICE – Word, Excel Power point

Training Details
ISO 9000:2000 Transition Auditor Training Course – By SGS International, Hyderabad.
Special Training on Foley Catheter Manufacturing – At Rusch Sdn. Bhd., Malaysia.
Computer Aided Mould Analysis – by C.I.P.E.T, Chennai TCS AC Tech, USA.
Quality Control Testing of Plastics – By Central Inst. Of Plastic Engg. Technology, Chennai

Skill Sets

Production Planning & Control, Quality.

Work Experience

Manager – Technical & Production.
Jan 2007 to till date
Company Profile : E.O.U manufacturing various types of Natural Rubber,& Finger Cots, Korean & German Technology ; possess U.S FDA 510 (K) Approvals & CE, NF Mark, ISO 9001, ISO 13485 accreditation, S.A.B.S Mark, W.H.O-G.M.P.
Job Profile
Reduced the rejection rates of condoms from 35% to 8% in German Technology dipping lines.
Trials conducted to reduce the cost / chemical usage in the dipping and treating process.
Monitoring of the process and control of defects on-line itself.
Planning for the production of condoms for on-time delivery of products.

Manager – QA & Regulatory Affairs
Nov 1998 to Dec 2006
Worked with Indus Medicare Limited, Hyderabad, India
Company Profile
100 % E.O.U manufacturing various types of Natural Rubber, in Technical Collaboration with Richter Hi-tech, Germany; possess U.S FDA 510 (K) Approvals & CE, NF Mark, ISO 9001, ISO 13485 accreditation by L.N.E, FRANCE, Canadian regulations (CMDCAS), W.H.O-G.M.P.
Job Profile
Carried out inspection of Twin Dipping Line, E.T & Foiling machines at Richter Rubber Technology, Malaysia and approved for purchase.
Instrumental in improving washing process of condoms, which contributed an annual savings of Rs. 3.5 lakhs.
Associated with the company since inception; planned, organized and set up equipments for testing incoming & in-process materials and products.
Effectuated QMS within short duration and obtained certification for ISO 9002, CE mark, within 8 months, without any External Consultancy.
Obtained Pre-Market Approvals {510 (k)’s} for all U.S.A Exports (Products).
Holds the distinction of transforming ISO 9002 to ISO 9001 & EN 46002 to ISO 13485.
Awarded minor discrepancies in all Certification, Regulatory Audits & Inspections.
Rare failures in lots which are tracked by 3rd party and tested in external laboratories (Labs in Australia, Singapore, Sweden, USA, France, India etc )
Successfully resolved disputes raised regarding Final Product Quality in External Laboratory Testing (S.G.S, India & S.A.B.S, South Africa)
Developed production process for Novelty condoms based on the sample given.

Executive Q.A
Jan 1996 to Nov 1998
Worked with Rusch A.V.T Medical Ltd, Pondicherry, J V between A.V Thomas group & Teleflex Inc., U.S.A
Company
Rusch Latex Foley Catheters (Sterile Disposable Medical Devices)
Job Profile
Joined at the inception stage and oversaw all works. Also implemented Q.S within short duration.
Authored Quality Specifications as per British Standards and prepared control documentation as per ISO 9002.
Monitored and controlled all Q.C & Q.A activities as well as conducted Training, Quality Audits, Supplier Audits, Validations and Calibrations.
Developed the entire Layout and established the set-up of laboratory for all the required tests.

Executive Q.C
March 1990 to Jan 1996
Worked with Trans Plastics (I) Ltd., Pondicherry,
Product: Transmed – Syringes, Endotracheal tubes, IV Cannulae, IV Sets etc. (Sterile Disposable Medical Devices)
Job Profile
Played a major role in monitoring and controlling the Quality Systems thereby ensuring compliance as per I.S & D.I.N standards.
Handled operations in personnel monitoring, Toxicity, Pyrogen & Sterility tests.
Successfully tracked the defects & suggested for remedial action there attaining improvements.
Instrume ntal in improving quality of products by analysis & suggestions as well as involving in production activities (Team work).

Shift Chemist
Jan 1989 to Feb 1990
Worked with Vedha Chemicals (P) Ltd., Pondicherry
Product handled: Magaldrate – Bulk Drug (Antacid)