Computer System Validation

Job Description

Ensure computerized systems are appropriately validated.  Provide implementation or upgrade project team with (expert) computerized systems validation (CSV) guidance. Help project teams define appropriate computerized systems validation strategies. Prepare or review all levels of validation documents (internal or external SDLC) including:

Validation (Strategy) Plans, User Requirement Specifications.

Definition Documents, including Functional Specifications S/W Design Specifications or Configuration Documents and SOPs.

Qualification Documents and Test Specifications (DQ, IQ, OQ, PQ).

Traceability Matrices and Risk Analysis.

Validation Reports, Change Controls Procedure / Events / Deviation Handling, Document Management and CAPA management.

Provide CSV technical sign-off for all the above. Provide training on Computerized System Policies, SOPS, industry regulations trends and “hot topics” to project team, members, system owners and users. Perform audit as CSV subject matter expert, suppliers of computerized systems or external service providers. Works closely with the Implementation Team, Security and e-Data Compliance team to ensure requirements for electronic data security and e-data management as defined and delivered during any implementation or project upgrade. Should have adequate understanding on Change Control Procedure, Deviation Handling, Document Management and CAPA management. Well-organized and detailed oriented professional, with strong verbal and written communication skills.

Desirable Qualifications

• BE / BTech / MCA with exposure to life sciences / pharmacovigilance domain and drug safety applications
• End to end understanding of regulatory guidelines and required documentation for new system release, understanding of risk-based system validation approach
• Ability to lead a team of CSV professionals.
• In depth understanding of 21 CFR part 11 compliance, in depth understanding of the regulatory guidelines for IT systems – primarily FDA.
• Well-organized and detailed oriented professional, with strong verbal and written communication skills.
• Self- motivated with ability to handle, organize and prioritize multiple tasks and ability to perform under pressure to meet strict timelines.
• Proven ability to identify quality issues/discrepancies and effectively and proactively resolve the issues / discrepancies in a diplomatic, flexible and constructive manner.
• Understanding of SQL queries.
• Experience with electronic document management system is an added advantage.
• Guide the product / project team on the CSV impact for all the change controls & best practices.
• Audit experience on IT systems, SOP and template authoring experience.
• Experience of working in an agile / scrum team structure.

Duties and Responsibilities

• Authoring and reviewing the CSV documentation - Test Plan,  DQ, IQ, OQ, PQ for AETracker products and projects in PV domain.
• Assist in Quality Investigations and CAPAs.
• Provide first level of guidance and support to the project teams on CSV approach required for a planned change.
• Participates in internal product audits and supporting external audits.

Processes and provides timely and accurate update on the assigned duties to the reporting manager.

• Participates in the revision, review, and approval of SOPs and controlled templates.
• Should be able to achieve the optimum balance for quality v/s productivity.

Job Location

• Bangalore, India.

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.