Pavan K. Kumar
Sr. Manager-Quality Assurance
Hyderabad
Summary
Aiming for challenging position in quality assurance department to apply skills and technical capabilities in pharmaceutical field, ensuring security and professional development while being resourceful, innovative, and versatile
Overview
14
14
years of professional experience
1
1
Language
Work History
Sr. Manager- Development Quality Assurance
Cohance Lifesciences (DQA)
- Current
- Ensure the compliance of Technology Transfer documents related to R&D,ARD and DQA.
- Review of product development report and ensure compliance
- Quality management system compliance in respective department, ensuring incidents, deviation and change management implementation and addressing CAPA through route cause analysis.
- Conducting internal audits.
- Setting of specification review and approval, stage wise during product development.
- Review of analytical method validation, protocols, chromatograms, reports and ensure the compliance.
- Impart training program in respective departments on technical and procedural oriented sessions/current guidelines.
- Review and performing GAP analysis within SOP’s versus practice
- Ensuring data integrity w.r.t laboratory note book (LNB) and analytical data and assure smooth and error free technology transfer.
- Perform external audits of analytical laboratories/sites
- Performing vendor qualification during product development and ensure procedure compliance.
- Review of CSV documents and ensure the compliance of SOP in the site.
- Review of regulatory support documents and ensure the compliance
Manager- Quality Assurance
Honour Labs (CQA/DQA)
08.2022 - 09.2024
- Ensure the compliance of Technology Transfer documents related to R&D,ARD and DQA.
- Review of product development report and ensure compliance
- Quality management system compliance in respective department, ensuring incidents, deviation and change management implementation and addressing CAPA through route cause analysis.
- Conducting internal audits.
- Setting of specification review and approval, stage wise during product development.
- Review of analytical method validation, protocols, chromatograms, reports and ensure the compliance.
- Impart training program in respective departments on technical and procedural oriented sessions/current guidelines.
- Review and performing GAP analysis within SOP’s versus practice
- Ensuring data integrity w.r.t laboratory note book (LNB) and analytical data and assure smooth and error free technology transfer.
- Perform external audits of analytical laboratories/sites
- Performing vendor qualification during product development and ensure procedure compliance.
- Review of CSV documents and ensure the compliance of SOP in the site.
- Review of regulatory support documents and ensure the compliance
Deputy Manager- Quality Assurance
Granules India Limited (R&D-QA)
05.2018 - 08.2022
- Review, revision and approval of all department SOP’s
- Quality management system compliance in respective department, ensuring incidents, deviation and change management implementation and addressing CAPA through route cause analysis.
- Scheduling and conducting internal audits
- Review of product development reports
- Setting of specification review and approval, stage wise during product development.
- Review of analytical method validation, protocols, calculation sheets, chromatograms, report and review of electronic data.
- Impart training program in respective departments on technical and procedural oriented sessions/current guidelines.
- Review and approve of equipment qualification protocols and reports.
- Review and performing GAP analysis within SOP’s versus practice
- Ensuring data integrity w.r.t laboratory note book (LNB) and analytical data and assure smooth and error free technology transfer to manufacturing site.
- Setting of document management procedure and maintenance of documentation cell.
- Approval of stability protocols and continuous monitoring for compliance.
- Perform external audits of analytical laboratories.
- Conduct discussion on setting of product specification and gate clearance stage-wise circulate minutes of meting to respective departments.
- Review and sending of technology transfer documents and conduct technology transfer meetings by coordinating with concerned units.
Junior Manager-Regulatory Affairs & Development Quality Assurance
Emmennar Pharma Private Limited
10.2016 - 04.2018
- Preparation and review of SOPs (DQA/R&D/AR&D/RA)
- Maintenance of Change Controls, Incidents and Deviations, Customer Complaints.
- Preparation & Compilation of DMF (Applicant part/Restricted part) for Regulatory and ROW markets
- Responsible for Compilation of CEP Revisions/Renewals.
- Responsible for Evaluation of product change controls and submission of technical amendments.
- Responsible for Handling deficiencies
- Co-ordination with cross functional departments to compliance the DMF queries
- Responsible for review of technical data and ensure the compliance for DMF compilation.
- Responsible for review of Product development and Analytical Method development data review and to ensure the compliance to the Technology Transfer
Executive- Development Quality Assurance
MSN Laboratories Private Limited
09.2015 - 10.2016
- Preparation and review of SOPs (DQA/R&D/AR&D/RA)
- Maintenance of Change Controls, Incidents and Deviations, Customer Complaints.
- Preparation & Compilation of DMF (Applicant part/Restricted part) for Regulatory and ROW markets
- Responsible for Compilation of CEP Revisions/Renewals.
- Responsible for Evaluation of product change controls and submission of technical amendments.
- Responsible for Handling deficiencies
- Co-ordination with cross functional departments to compliance the DMF queries
- Responsible for review of technical data and ensure the compliance for DMF compilation.
- Responsible for review of Product development and Analytical Method development data review and to ensure the compliance to the Technology Transfer
Chemist-Quality Assurance
Everest Organics Private Limited
02.2012 - 08.2015
- Monitor vendor evaluation procedures (Vendor assessments on site-vendor audit)
- Participate in regulatory and customer audits.
- Coordination of Periodic Internal Quality Audits
- Verification and issuance of Analytical investigations, Customer complaint Change controls investigation and close the investigations.
- Validation raw data and AR&D formats and Complaints and changes in a timely and with effective CAPA timely.
- Preparation and review of SOPs, Site Master File and product reviews (APQR) and implement recommendations/conclusions
- Qualification of Equipments, Clean Room & Water system
- Vendor Qualification (Review of Vendor and file the DMFs (various types), its amendments and updates.
- Preparation and sharing of Open Parts of DMF with the customer responding to their queries.
- Preparation and review of all type of documents (SOPs, Master Formula, BPRs, Protocols, reports, stability protocols, validation) reports to support technology transfer
- Support of drug license activity for Test, Domestic, Export, DCGI, Manufacturing
- Issuing and Retrievals of SOPs, BPRs, Raw Data sheets, Formats and other quality related Documents.
- Coordination of Periodic Internal Quality Audits, Trainings.
- Ensuring non-conforming products are identified and placed on restriction
- Daily monitoring of plant and checking all the parameters in compliance with cGMP
- Use of vendor questionnaires, providing the different types of declarations
Education
M.Pharmacy - Pharmaceutics
RRK’s College of Pharmacy
Nawbad, Bidar08-2015
B.Pharmacy - undefined
RRK’s College of Pharmacy
Nawbad, Bidar01-2011
Intermediate-Bi.P.C - 10+2
Nagarjuna Junior college, Board of intermediate education
AP01-2006
SSC - 10th
Sri Guru VidhyaNikethan High School, Board of secondary Education
01-2004
Skills
Quality Management System
Technology Transfer
Vendor Qualification
Internal Audits
Ability to deal people in good way, co-ordinates well with team members and to have complete dedication towards work ship
Hard working, Sincere and punctual
Self-learning
Chnage controls
Lab Investigations
Risk Management
Profile
M. Pharmacy (Pharmaceutics), 14, 2012-02-01, present, Sr. Manager, Development Quality Assurance (DQA), 2024-10-01
Personal Information
- Date of Birth: 16-05-1989
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Personal data processing
I hereby assure that the above furnished details are correct up to my Knowledge and I bear the responsibility for the correctness for the above-mentioned particulars.
Timeline
Manager- Quality Assurance
Honour Labs (CQA/DQA)
08.2022 - 09.2024
Deputy Manager- Quality Assurance
Granules India Limited (R&D-QA)
05.2018 - 08.2022
Junior Manager-Regulatory Affairs & Development Quality Assurance
Emmennar Pharma Private Limited
10.2016 - 04.2018
Executive- Development Quality Assurance
MSN Laboratories Private Limited
09.2015 - 10.2016
Chemist-Quality Assurance
Everest Organics Private Limited
02.2012 - 08.2015
Sr. Manager- Development Quality Assurance
Cohance Lifesciences (DQA)
- Current
M.Pharmacy - Pharmaceutics
RRK’s College of Pharmacy
B.Pharmacy - undefined
RRK’s College of Pharmacy
Intermediate-Bi.P.C - 10+2
Nagarjuna Junior college, Board of intermediate education
SSC - 10th
Sri Guru VidhyaNikethan High School, Board of secondary Education