CSV Validation Engineer

4 weeks ago

India PrimeForce Solutions Full time

Company Description PrimeForce 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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