Harsha K.T.

Senior Executive at Acebright Pharmaceuticals Group Co.,Ltd.
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Contact Information
us****@****om
(386) 825-5501
Location
Bengaluru, Karnataka, India, IN
Languages
  • Kannada Full professional proficiency
  • English Professional working proficiency
  • Hindi Professional working proficiency
  • Telugu Elementary proficiency

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Experience

    • China
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Senior Executive
      • Nov 2016 - Present

      Quality Control, Analysis, SOP, Specifications, Trouble shooting, HPLC, Learning GC Quality Control, Analysis, SOP, Specifications, Trouble shooting, HPLC, Learning GC

    • India
    • Pharmaceutical Manufacturing
    • 300 - 400 Employee
    • senoir executive - Quality assurance
      • Feb 2016 - Oct 2016

      Review of analytical reports, product releases, lab compliances, GLP, GDP, Review of analytical reports, product releases, lab compliances, GLP, GDP,

    • United Arab Emirates
    • Chemical Manufacturing
    • 700 & Above Employee
    • Development Chemist
      • Dec 2011 - Feb 2016

       Testing of raw materials, and finished product samples as per compendial methods and in-house procedures. Responsible for author and revise QC SSOPs, Specifications and test methods as necessary to maintain compliance.  Reviewing of Quality Control raw data for accuracy, completeness and compliance with effective SSOPs to ensure the strength, identity, safety, purity and quality of the product.  New vendor development, approval, periodical audits and feedback to vendors.  Training and guiding the QC team to achieve established Quality objectives and targets.  Product development as per the customer requirement. (Chemical grinding aids, Admixtures, Grouts).  Demonstration and validation of product stability at different conditions.  Good housekeeping activities and lean management at QC and R&D.  Test trails, market strategy and implementation of products, support to sales team in introducing new products.  Responsible for conducting and coordinating internal audits with respect to Quality and EHS.  Coordinating for day today activity of QC  Conducting periodic meeting of safety committee.  Conducting incident investigation by completing in depth route cause analysis and suggesting the team about proper corrective and preventive actions.  Educating the various stake holders like suppliers/service providers/contractors to achieve best performances in EHS  Continuously strive to improve the QC performance. Show less

    • India
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Oncotherapies QC executive
      • Mar 2011 - Oct 2011

       Handling and analysis of cytotoxic products, mainly Tablets, Parenterals and lyophilized samples.  Analysis of process validation and cleaning validation samples.  Instruments handling – HPLC, Dissolution, Disintegration, KF Titrator, Autotitrator etc.  Sampling of finished goods, especially bulk tablets and raw materials.  Conducting Safety meetings periodically.  Identification and organizing Waste minimization, Energy Efficient and Green initiatives among various departments across the company. Show less

    • United Kingdom
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Associate - QATS
      • Sep 2006 - Jan 2011

      Analysis of Raw materials, Finished products, Post-production stability samples, Formulation development trials, Bulk drug plant samples and Prostaglandin synthesis lab samples. Sampling of Raw materials, Bulk drug and Prostaglandin. Validation and calibration of laboratory equipments ( HPLC (Make – Agilent 1100 & 1200 series), Dissolution test apparatus (Make – Electro lab & Lab India), Balances (Make - Mettler Toledo & Sartorius), pH meter (Make - Systronics), UV Spectrophotometer (Make - Shimadzu), Viscometer (Make - Brookfield)) Operation of SAP Timely training to new entries. Good laboratory practices Preparation of working standards and documentation. Maintenance of Instrument log books, HPLC columns, Mobile phase registers, Chemical and glassware stock. Preparation of Standard operating procedures for QC activities. Review and updating of specifications. Preparation of Certificate of analysis. Strong exposure to global SHE (Safety, Health and Environment) policies and performing OEL studies (Occupational exposure limit) as a global SHE requirement for every quarter. Review of analytical reports for GLP compliance Good housekeeping activities. Show less

Education

  • Shiva gangothri
    Master of Science (M.Sc.), Biochemistry
    2004 - 2006
  • Jawahar Navodaya Vidyalaya, Balehonnur
    Class 10th, Kannada, English, General Science, Social Science,Mathematics
    1992 - 1997

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