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 performing impact assessment for GxP applications and closure of the same. Cloud migration strategy document, review and approval of test cases/Results. Assessment, Gap assessment, periodic review of implemented applications and infrastructure for the compliance inline with current regulatory requirements.  Internal audits, GAP Assessment of Applications and infrastructures against the current regulatory requirements. Co ordinating with project team/stakeholders for timely creation/review /approval of validation deliverables in-line with GxP compliance. Review of all validation deliverables like URS, FRS, Design, IQ, OQ, PQ document. Providing training and guidance to the Project team/Stakeholders on CSV requirements.

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). Validation and qualification for the QC and production instruments. Validation and technology transfer of Products (Analytical and manufacturing). SDLC deliverables like URS, VMP, IQP, OQP, RTM, Scripts and validation of any changes in software workflows in operational and maintenance phase. Training (GMP, GLP, GxP) to the end users on topics such as Compliance, revised software workflows etc. Analytical Quality assurance,  Lead for handling IT quality audits and assessment of suppliers for computerized systems. Maintenance of regulatory compliance in line with 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). Review of validation and qualification for the QC and production instruments. Management of user accounts for the software’s and audit trail review of instruments, equipment’s and utilities  Involved in validation and technology transfer of Products (Analytical and manufacturing). Responsible for review of SDLC deliverables like URS, VMP, IQP, OQP, RTM, Scripts and validation of any changes in software workflows in operational and maintenance phase. Responsible for providing training (GMP, GLP, GxP) to the end users on topics such as Compliance, revised software workflows etc. Handling Analytical Quality assurance, QMS, IT QA for Pilot plant Dabaspet for GXP compliance.

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 and finished product CoAs in adherence to GMP standards, pharmacopeia, Indian FDA requirements are released for packing and to the market.  Handling of M-ERP System related to batch release and other QA transactions.  To perform internal audits at the site and time bound compliance to L3 and L4 audits and CAPA tracking for the site level.  Support on Validations, execution of Developmental Batches, QMS, and GPS rollout in site; backup support for operational quality manager.  Support Routine commercial batch manufacturing and packing activity on document review role of operational quality. Routine GEMBA and ensures timely closure of GEMBA observations.  To support and ensure site’s Inspection readiness of manufacturing facility and no overdue actions in Carisma (Deviations, CAPAs associated with WH, Manufacturing, Engineering and Operational Quality).

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 Coordinator handling of change control at Apotex India.  Team member for the implementation of QMS Trackwise for audits.  Quality Agreement negotiations and ensure compliance with Quality Agreement terms.  Risk assessment of Excipients as per EU guidelines.  Handling of supplier driven changes received from the suppliers.  Impact assessment of Supplier notifications which impacts on quality of the material.  API transport evaluation, handling commercial alerts and impact assessment.  Quality agreement Preparation, review and execution.  Review of global SOP and adoption of GSOP to Site SOP.  Involved in USFDA, TGA, MHRA and Health Canada Audit.

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 Quality Management System at contract manufacturing sites.  Technical document review and execution of new products launch to Biocon Health care.  Suppliers audit schedule preparation, co-ordination and execution of audits.  Suppliers CAPA review and timely closure of audits. Core team member for handling analytical and manufacturing technology transfer to contract manufacturing sites.  Core team member for audit of customer and regulatory handling at Contract manufacturing sites.  Preparation and Execution of process validations of Sterile Dosage forms , Solid Oral Dosage forms (Tablets and Capsules), and Semi-solid Dosage forms.  Co-ordination with regulatory, Quality control, Formulation and Analytical development departments for the Dossier submissions for ROW market.  Organizing and conducting GMP training’s for manufacturing and supply chain personnel.

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 development departments for the Dossier submissions for ROW market. Handling of regulatory Quires for ROW market. Preparation of SOP related to corporate Quality Assurance. Preparation and review of process validation protocol, sampling plan, stability study and hold time study protocol. Compilation and Review of Data required for the dossier submission. Involved in Handling Customer Audits for Domestic Market. Preparation of Annual product review and Statistical Evaluation of Process validation data for Regulatory requirement. Faced Audit from Ukraine, Brazil, Egypt, Iran and other International customers. Implementation of QMS in the contract manufacturing sites. Handling of customer complaints and Market complaints. Release of Batches in ERP, Code creation, BOM approvals and yield reconciliation through ERP.

 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, In-process, finished products analysis Raw data and responsible for the Release of the Batches at contract manufacturing sites. Release of Batches in ERP, Code creation, BOM approvals and yield reconciliation through ERP.  Preparation, Review and Approval of Raw material, Packing Material, In-process and Finished product Specifications. Preparation and review of Master formula records, Master batch manufacturing records, Master packing records and Batch packing records. Handling of in process Quality Assurance activities (Line Clearance, Sampling, Batch record review CGMP compliances, Assurance of product Quality by checking in process parameter)

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. Coordinating in preparation of investigation report for market Complaints.

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