CSV Validation Engineer

7 days ago

Vadodara, India PrimeForce Solutions Full time

Company DescriptionPrimeForce Solutions is a global R&D solutions provider specializing in the life sciences industry. Our team's expertise in life sciences processes and technical knowledge allows us to deliver high-quality services to our clients. We focused on providing top-notch service to our customers.Requirements:Primeforce Solutions is looking for a Business Systems Analyst/Validation Engineer for a full-time role. Prior experience in validation of Clinical/Document Management/Regulatory systems is a big plus. Demonstrated working knowledge of GAMP 5, “A Risk-Based Approach to Compliant GxP Computerized Systems" is a must. Essential Job Function:● Validation activities for GxP systems. Proven experience developing full validation documentation and testing protocols (URS, IQ/OQ/PQ/UAT, Change Controls, Deviation, CAPA) within the various SDLC phases. ● The Business Analyst will also be involved in performing periodic review and data integrity assessment of enterprise systems.● Management of application access and permissions.● Perform change management activities.● Resolution of technical Issues.● Creation of reports as needed.● Support user training.● Maintenance of system documentation. Author and develop standard operating procedure and work instructions required for application support and maintenance.● Prior experience working in validated systems within a GMP/GxP environment is mandatory.● Experience of working both independently and in a team-oriented, collaborative environment is essential.● Flexible during times of change.● Can conform and swiftly adjust to shifting priorities, demands, and timelines through analytical and problem-solving capabilities.● Manages complex issues and risks and troubleshoots them as they arise.● This role will regularly interface with all levels of the organization and with external vendors. Core Competencies, Knowledge, and requirements:● 5+ years of experience working on supporting applications. ● 3+ years of experience working on validated applications in a pharmaceutical or regulated environment.● Experience with any regulated (GxP) applications, such as Master Control Quality Suite, Veeva Vault, Quality, RIMS, eTMF, or other Veeva Vault Platform applications would be an asset.● System administration experience with GxP applications.● Basic database, SQL, and computer networking knowledge.● Experience working on Software-as-a-Service (SaaS) systems. Prior experience is desirable.● Basic programming or scripting knowledge is nice to have, python or java.Education● Bachelor’s degree in computer science or MIS or Master’s in computer applications, or a related computer-oriented discipline.Other Qualifications:● Strong written and oral communication skills.● Strong interpersonal skills.● Excellent interpersonal, communication, analytical and organizational skills.● Skilled in conflict resolution/negotiation. Fosters open communication. Listens and facilitates discussion.● Team player capable of managing multiple systems and complex timelines in a team environment.● Ability to problem solve and trouble shoot under pressure.● Work independently under general supervision.● Ability to prioritize and handle multiple projects simultaneously and work in a global environment across several time zones.● Effectively communicate project expectations to team members and stakeholders in a timely and clear fashion.

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