Pankaj Dubey

I am responsible for shaping comprehensive validation strategies and meticulously reviewing Computer System Validation (CSV) deliverables for IT projects.

Additionally, I actively support the Quality eCompliance team's initiatives across Corporate/PPL sites, ensuring seamless alignment with organizational objectives.

My role involves conducting thorough IT Supplier assessments and diligently overseeing compliance with audit observations.

I foster effective communication by collaborating with Site ITC SPOCs for CSV activities and various IT Compliance initiatives.

Furthermore, I take pride in guiding and training both Corporate and Site IT & CSV teams, equipping them with essential skills and knowledge related to CSV, Data Integrity, and Regulatory Compliance activities. My dedication lies in ensuring the highest standards of quality and compliance within our organization.

I was responsible for engaging and promoting the compliance at every opportunity, managing, and working with Quality Assurance and Cross functional teams. I have also delivered a successful tenure as Quality Assurance Validation lead with delivery of the various technology transfer and new projects. My current responsibilities include:
• Leading Computer System Validation over the site.
• Involved in developing, and reviewing Computer System Validation deliverables in compliance with Annex 11, GAMP 5, FDA 21CFR Part11, CFR Part 210 and GxP GLP, GCP, GMP Compliance Regulations
• Review and approval of CSV deliverables Validation Project Plan, URS, TM, IQ, PQ, UAT, Vendor Postal Audit Report, Computer System Risk Assessment, Periodic Review Report, Decommission Report, and Validation Summary Report.
• Monitoring KPI Weekly/Monthly/Quarterly/Annually.
• Co-ordination with IT to maintain server qualifications both application and the database servers.
• Deviation Expert and responsible for the conducting/supporting effective investigations.
• Risk Analysis & management for the critical/new systems
• Responsible for the simplification of the processes.
• Certified cGMP technical trainer for the site.
• Certified lead internal auditor for the site and performing self-Inspection of Engineering and cGMP areas.
• Co-ordinate with the vendors in commissioning of the instruments upgrade software, implement new system or maintenance of systems and system suitability tests
• Compliance and evaluation of the local system with Data integrity policy.
• Developing Business Continuity Plan (BCP) for the disaster management as per BS EN ISO 22301:2019.
• Super user of Track wise for Quality Management System.
• Site Deployment Lead for the Veeva Vault QualityOne QMS Application.
• Super User of QualityOne for Quality Management System.

• Responsible for monitoring, evaluating and reporting on quality performance indicators
• To ensure compliance to Regulatory Guidelines.
• Review of validation/Qualification Protocols and Reports.
• Quality Risk Assessment and its implementation.
• Handling of Customer Complaints and investigation.
• Preparation of Audit Compliance Reports and CAPA Tracking.
• Handling of deviations and investigation.
• Compliance Improvement plan Monitoring.
• Handling of internal and external Audits.
• Computer System Validation
• Handling of Sales Return

• Handling of QMS (Expertise in investigative skills with respect to Incidents and Market complaints).
• Quality Risk Assessment (Training, handling and control)
• Review of Validation Documents ( Equipment, HVAC, Water and Computer system Qualification, Process and cleaning Validation)
• Certified trainer for the cGMP trainings
• Safety Star CAP owner for the department
• Key Team Member of Quality Observation and Interaction Team
• Key Member of Safety Incident and investigation Team
• Handling of Audit and preparation of Compliance Report
• Review of Change control and impact before the implementation.
• Tracking of CAPA.

o Review and approval of Equipment qualification documents.
o Preparation of all the master documents like Site Master File, Validation Master Plan, Cleaning validation Master plan, Quality Manual, Standard operating procedures etc.
o Review and approval of Engineering related SOPs.
o Review of change control and Deviations.
o QMS- Review of change controls, deviations, Incidents (Nonconformance reports).
o Handling of Customer Complaints and investigation.
o To Prepare & review risk analysis of the equipment using tools such as FMEA as part of Quality Risk Management.
o Learning about qualification philosophy and procedure.
o Learning about Incident Investigation skills etc.

o IPQA activities in manufacturing and packaging areas.
o Sampling of In-process and finished products.
o Monitoring Process validation from different stages of the process as per approved protocol.
o Issuance and control of documents like BMR, BPR, and SOPs.
o Swab sampling from different locations of the equipment to verify the cleaning procedure.