Hari Gowda Email & Phone Number

India

 Validation Manager for Life science Applications, Client implementation, infrastructure qualification and Production support Projects. Validation of healthcare applications through V model, Agile methodology (Risk Assessment, validation plan, RTM and summary report of applications and infrastructure). Change requests, Incidents, Defects requests and.

Greater Bengaluru Area

 IT quality audits and assessment of suppliers for computerized systems. Regulatory compliance (USFDA, EU and other regulatory authorities) for computerized system and infrastructure of implemented systems. Equipment’s and Area Qualification for the Green field project in coordination with Suppliers for FAT, SAT and qualification (IQ, OQ and PQ)..

Vemagal Bangalore Karnataka

Assessment and Review of quality related documents MFRs, BMR, BPR, SOPs/SWIs (VSWIs (Manufacturing, WH, Engineering) and associated documents to ensure to meet the regulatory and QMS requirements.  Review of QWF records (Change control, deviation and CAPA), Deviations, RCAs, Incidents, CAPA.  Review of Batch Manufacturing Records, Batch Packing Records.

Bangalore, India

Handling of Supplier qualification and assessment of vendors.  Responsible for scheduling audits for API, excipients, packaging materials and service providers.  Tracking of Audit observations, response, CAPA verification and closure with in the defined timelines.  Review and risk assessment of CEP suspensions and withdrawals.  QMS Trackwise CCR.

Bangalore India

Conducting suppliers audit to ensure regulatory compliances for API, excipients, packaging materials and service providers.  GAP Assessment and verification of feasibility of contract manufacturing sites.  Technical Quality Agreement review and execution for the suppliers and contract manufacturing sites.  Effectively involved in the implementation of.

Biocon Bangalore

 Technical Quality Agreement review and execution SAP implementation in QA module Preparation and Execution of process validations of Sterile Dosage forms (SVP, Dry Powder and Lyophilized), Solid Oral Dosage forms (Tablets and Capsules), and Semi-solids (Ointments and Creams). Co-ordination with regulatory, Quality control, Formulation and Analytical.

 Preparation of DCGI Documents required for the Licensing purpose. Issuance and control of documents to contract manufacturing sites. Deputed to Baddi for four Months to implement cGMP practices at Contract manufacturing Sites. Preparation of Master Formula Record, Packing master Record, Batch Record, Packing Record. Review of Executed BMR, BPR.

Bangalore

 Review of Analytical data for the finished product analysis raw data, Stability studies raw data and analytical validation data. Manufacturing assurances for the Contract manufacturing sites. Preparation of Raw materials Specifications, Packing material specifications and review of Artworks for the compliance against Drugs and cosmetics Act 1948..

Completed 45 Days of Industrial training from Mahendra labs Pvt Ltd., Bangalore, as a part of B. Pharmacy academic activity. During this period, training was taken in various departments of production like Tablet, Capsule and Liquid orals and also in Quality Control Department.

Pharmacy, Pharmaceutical And Medicinal Chemistry

Activities and Societies: CRICKET and Playing with chemistry Publication of research papers

Master Of Pharmacy, Pharmaceutical Sciences

Secondary School Learning Certificate