Raghavender Gunda MSc, MBA, DGMP

Experience

• 

  Sanofi

  Oct 2007 - Sept 2014

  Job Role:1. Audit & Compliance Conducting GMP Audis effectively certification. Member in internal and external audit and compliance team. Risk analysis to schedule Audits. Preparation of Audit Plan, Circulation and Conducting Internal Audits as per In-house SOPs and Audit Plan.  Key member in supplier/vendor (raw material, equipment) audits.  Preparation of audit observations and follow up of CAPA. Preparation of Audit summary report for Management review. Knowledge in Handling Regulatory Queries.2. R&D seed/ cell bank and clinical trial material management . In-charge for R&D seed/ cell bank and clinical trial material management. Setting up of R&D seed/ cell bank and clinical trial material storage facility for R&D. Inventory, issue and control of R&D seed/ cell bank and clinical trial material.3. Training and Education Qualified Trainer by the in house SMEs. Preparation of Annual Training Schedule. Training coordinator for R&D and Manufacturing Technology functional groups. Conducting Training for R&D, Production, QC and Manufacturing Technology department members on Quality systems, SOPs and on guideline requirements. To provide training for the shop floor people. Show less Job Responsibility:1. In-Process Quality Assurance In-charge for R&D seed and cell bank management. Ensuring GMP/GLP aspects in the facilities and follow ups. Ensuring compliance to In house procedures (SOPs, STPs & Site procedures). Responsible for Line clearance for manufacturing activities. In Process monitoring of manufacturing activities. Ensure EMP status in the facility and reviewing EMP trends. Monitoring and ensuring the labeling activity and dispatch activity of DS/DP. Monitoring and ensuring the Destruction activity of rejected bulk, blend, final products and Investigational products (IPs).  Ensuring and coordinating the Product Change over process in the facility. Review of executed LOT/Batch Records, BMRs & BPRs along with testing reports and COAs. Responsible for Batch Release/Rejection. Approved Analyst from the DCGI for Batch release activities.2. Documentation System Maintenance & Documents Review Document numbering system maintenance. Preparation of Quality System related SOPs and procedures. Review of documents (Study Designs, Study Protocols, Technical Reports, Work Protocols, Development Reports, Qualification Reports, Method Validation Protocols, Stability Protocols, Stability Reports, Testing Reports, Study Reports, Offline Reports, STPs, SOPs, Specifications, URS, Transfer documents, IQ, OQ, PQ and RSTs) received from R&D, QC, Production functional groups. Documents Issue, Control, Archival and maintenance. Preparation of annual quality review documents. Master documents scanning activity monitoring, maintenance, control and archival (Document soft copy management). Review of MSDS (Material safety data sheet), PSDS (Pathogen safety data sheet) and ECP (Exposure control plan). Show less

  • Senior Research Associate-Quality Assurance (R&D) - Shantha Biotechnics Limited. A Sanofi Company

    Apr 2013 - Sept 2014

  • Research Associate-Quality Assurance (R&D)

    Apr 2011 - Mar 2013

  • Research Assistant - Shantha Biotechnics Limited, Part of Sanofi Aventis Group

    Sept 2010 - Mar 2011

  • Production Assistant at Shantha Biotechnics Limited

    Oct 2007 - Aug 2010
• 

  Biological E. Limited

  Sept 2014 - May 2016

  Assistant Manager - Manufacturing Sciences Quality

  1. Responsible for Quality & Compliance of the Manufacturing Sciences department.• Reported to Associate Vice President & Head-Mfg. Sciences.• To ensure quality compliance of the activities performed in the Mfg. Sc. laboratory.• To ensure all the lab activities are performed as per QA / GLP requirements.• To assist in self-inspections; co-ordinate with SHE team for safety compliance.• To help in investigations, CAPA implementations, Risk assessments pertaining to the dept., in co-ordination with relevant staff and ensure their completion as per target dates.2. Documentation • To ensure online documentation of the activities performed in the Mfg. Sc. laboratory.• Responsible to verify the lab notebooks for its compliance and completion.• Responsible to verify the experimental raw data.• Preparation / Review of SOPs, Study design, Study Reports & any other documents as per requirement.3. Equipment Qualification • To ensure equipment qualification status.• To coordinate with Engineering, QA & Vendor to carry-out the qualification of the existing & new equipment.• Responsible to review and verify the IQ, OQ & PQ documents. Show less

• 

  Mylan

  May 2016 - Aug 2018

  Deputy Manager Quality Assurance

  Quality Oversight at Third Party Manufacturers• Overseeing quality at TPMs for DS & DP manufacturing of various Biosimilar(s) viz., Trastuzumab, Bevacizumab, Adalimumab, Pegfilgrastim and Insulin analogs namely Insulin Glargine, Insulin Aspart and Insulin Lispro.• Reviewing and approving the partner Change controls, Deviations, OOS/ OOT, & CAPA.• Initiation of TrackWise change controls, deviations and OOS as per Mylan requirements.• Support in reviewing Analytical raw data. Ensure COAs complies with the releasing criteria. • Review of Stability data.• Batch Release for India, ROW, US & EU regions.• Handling complaints, and Recalls.• Evaluation of CMOs and performing periodic audits with the support of Global Quality Audit teams.• Interaction with Global Vertical Quality teams for products registration in new markets. Show less

• 

  Hetero

  Aug 2018 - Jan 2021

  Manager & Lead - R&D QA

  • Responsible for Quality & Compliance of the R&D Laboratories.• Implementation of Quality System for R&D department.• To manage R&D QA shop floor team members, and to assign duties. • Project Coordinator from R&D QA for various Biosimilars under pipeline.• To ensure data integrity compliance at R&D.• To ensure stage gate compliance during product development and technology transfer.• Preparation, review of Quality system related SOPs, and to impart training to the shop floor team.• Approval of Risk assessments for development activities, e.g., viral clearance studies, process characterization, study reports etc. • Responsible for reviewing, authentication of raw data, and approving the Biosimilarity reports, Technology transfer related documents, and to ensure successful transfer to the site QA.• Responsible for review, and approval of various documents generated by R&D functions.• Review of R&D data in support of dossier finalization, and to support Regulatory Affairs team on addressing the different queries raised by various MOHs.• Monitoring of R&D seed, and cell banks.• To ensure all the R&D equipment / Instrument are in qualified state all the time.• Responsible for implementation of change management system. • Responsible for implementation of incident/ deviation management.• Responsible for internal and external audits management.• Scheduling internal audits & Preparation of audit summary reports for Sr.Management review, and approval. • To provide periodic trainings on QA procedures, and applicable guidelines to R&D staff.• To update R&D teams on GTC (Global Trends and Compliance).• Team co-ordination and team development.• To follow all the applicable EHS procedures, guidelines, and to commit for zero accidents at work place. Show less

• 

  Biocon Biologics

  Jan 2021 - now

  Manager - Quality Assurance

  Batch Release & QMS Manager