Computer Systems Validation Lead Job In Thermo Fisher Scientific In Bengaluru / Bangalore

• Drafting and approval of VAL Plan and Summary Reports for Projects and Change Management
• Mentoring the team on process improvements and proactively managing multiple projects/operations from CSV perspective
• Review and approve Project requirements (URS, FRS, SRS, Data Migration Requirements), protocols (pre and post - IQ, OQ, PQ, DMQ), Defects management in various GxP sensitive environments
• CHG Maintenance post go-live, periodic reviews and ensuring the project stays in a fully validated state from Regulatory and Compliance perspective
• Qualification/Validation of tools/utilities interacting with GxP sensitive environments
• Executing CAPA procedures, drafting and approving deviation logs and keeping artifacts audit-ready in MasterControl, ALM and Service Now tools A sound knowledge of QMS tools like MasterControl, HP ALM and CHG Management tool Service Now is preferred
• Review and draft standard operating procedures for tools refresh, upgrades, patching etc
• Coordinating with stakeholders for configuration and design specs update and overall Project CHG management

• Bachelor's Degree in Engineering, Science, or related field
• Must have a minimum of 3-5 years of experience in an FDA regulated industry
• Thorough knowledge of cGMP, FDA, CFRs and EU Annex 11 regulations and standards
• Ability to impact and influence people/areas in matters related to CSV and GxP compliance
• Use of HPALM and MasterControl a definite plus
• Experience with CHG Management over Service Now a plus

• A minimum of 3-5 years of experience working in a FDA regulated industry/organization
• 8-12 years of IT Experience over project delivery methodologies (like PMO, Software Testing, Development, Business analysis of IT applications), operations track (CHG Management), maintenance/support work, a thorough knowledge of SDLC is a must.
  
  
• Experience on the delivery of ERP systems like SAP over SD, MM, IM, WM modules would be a great bonus
• 1-2 years of Experience over Agile delivery methodologies would be a bonus

• Lead the development, harmonization, implementation, execution and adherence to validation procedures and methods related to computer systems validation (CSV)
• Preparation, review and issuing of CSV documents as they related to computer systems:
• Author, execute, perform and summarize CSV documents: Validation Plans, User and Functional Requirements, Design Specifications, Risk Management Plans, Installation/Operational/Performance Qualification Protocols, Traceability Matrices, Final Reports, Deviation Handling
• Evaluate proposed new computerized systems or software to assess GxP impact and where GxP impact is identified provides guidance on the risk based validation approach for the system, working with key stakeholders to achieve business goals
• Identify computerized systems validation needs through assessments and integration with IT Project Management Framework
• Support change control activities, deviations and SOP's for computer systems
• Participate in the development of Validation methodologies in accordance with applicable Quality/Regulatory requirements and industry best practices
• Work closely with IT, Business, Regulatory Affairs, and Quality to develop, coordinate and execute Validation documents and strategies
• Represent Validation in cross-functional team meetings/projects as required
• Effectively communicate with Leadership and all departments regarding Validation activities
• Organize and maintain validation documentation
• Recommend acceptance of the computer system, as determined from the CSV tasks performed on the system
• Maintain up to date knowledge of evolving regulatory requirements, availability of current/new techniques, and literature regarding compliant computer systems, and acts as an information resource for the team and wider business

Thermo Fisher Scientific is looking for Any Graduate / Post Graduate profile candidates.