Sheeba Gaurav

• Working as Quality, IT Compliance professional since February 2008
• Good understanding of quality methodology and processes
• Good experience of working in pharma/healthcare domain
• Good exposure of software development lifecycle for V-model and agile scrum projects
• Experience of quality management in pharma domain for around 7 years
• Planning and task management skills
• A high level of workmanship with an eye for detail
• Exposure to Data Integrity and EU GMP Annex 11 Compliance 

Self-directed and highly motivated team player with a great work ethic

• Serve as Quality reference for IT in regard to Validation of IT systems and Qualification of IT infrastructure
• As DI Compliance officer 
  • Lead the Data Integrity remediation program for 3 location (DE, CH)
    • Plan the scope of the program
    • Review the risk assessment and suggest remediation actions
    • Track the execution of progress
    • Act as the SPOC for all DI related topics in Audits for Computerized systems 
    • Reporting the Project progress to the Global DI team 
    • Ensure DI Compliance for manufacturing equipment and Software applications  
  • Participate in the review and approval of plans and reports related to the qualification (requalification) & validation URS, FAT, SAT, Risk analysis, IQ, OQ, PQ, computerized systems.
  • Qualification of equipment like Syringe line, Blister line , checkweigher .
  • Control the smooth running of qualification & validation operations in the field to ensure that the systems are operational and in a state of permanent validity.
  • Tracks execution of periodic review in a timely manner
  • Provide quality oversight in performance of Periodic reviews of computerized Systems.
  • Quality oversight in evaluation of changes to the infrastructure, interfaces and serialization systems.  
  • Approve SOPs, change requests and deviations related to computerized systems and IT Infrastructure
  • Ensure compliance with Data Integrity requirements 
  • Participation as internal auditor for Self-inspections 
  • Represent CSV QA in Client Audits
  • Establish the qualification requirements for the Infrastructure project, based on Annex 11 requirements
  • Established Audit trail review trainings and DI focus in CSV 
  • Share knowledge of specific Quality aspects in IT and across other parts of the organization
  • Assess current quality compliance situation and identify weaknesses or shortfalls
  • Keep current with changing and emerging regulations
  • Streamline and refining CSV process

Bachelors Degree in computer science