CSV Validation Engineer

5 days ago

India PrimeForce Solutions Full time

Job Description 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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