Computer Systems Validation (CSV) Lead

About the Company

Cognizant is a world leader in delivering digital transformation solutions to Life Sciences. Through our knowledge and expertise in Automation, MES & Digital, we deliver stable manufacturing systems that are optimised to improve operational efficiencies, whilst maintaining compliance. Our specialist engineering teams have the aptitude to deliver and support Pharma 4.0 architectures and solutions covering all IT, OT and IoT applications, infrastructures, and services.

About the Role

The Computer Systems Validation (CSV) Lead is responsible for Computer System Validation on Systems Integration Projects within the LSMG and will provide oversight and support for the Computerised systems that are being implemented as part of a major capital project to ensure compliance with regulatory expectations and company Computer Systems Validation (CSV) System Development Lifecycle (SDLC) and Data Integrity requirements. The CSV Lead will actively contribute to the overall validations.

Responsibilities

• Manage Computer System Validation projects from software install to business release.
• Providing independent quality review and approval of system lifecycle documentation such as plans requirements risk assessments protocols and reports for GxP systems including but not limited DCS automated equipment MES and associated local infrastructure.
• Providing input into the validation strategy for computerised systems including leveraging approach.
• Ensuring adherence to relevant regulations and company procedures including DI.
• Providing timely and pro-active CSV support and guidance to facilitate project timelines.
• Actively working with CSV colleagues within the project as well as the global CSV organisation to ensure alignment with other projects.
• Escalating any potential compliance issues in a timely manner.
• Generate computer system validation documentation in accordance with company procedures and GMP guidelines.

Qualifications

• Minimum 8 years’ experience validating IT applications e.g. requirements gathering design documentation test case development system & acceptance testing.
• IT qualification would be an advantage but not required.

Required Skills

• Past proven experience engaging business users to ensure that appropriate business needs are clearly defined communicated and delivered at or above expectations.
• Strong oral and written communication skills are required with proven ability to communicate and build relationships cross-functionally.
• Experience of server and workstation platforms and working in a Win 10 environment.
• Experience of SQL databases is an advantage.
• Experience of analysing and challenging s/w to identify gaps.
• Familiar with Annex 11/21CFR Part 11 requirements GAMP 5 and data integrity guidelines.
• Be self-motivated and develop an understanding of the business. and use initiative to identify and drive improvements.
• Experience of working in a pharmaceutical API manufacturing operation or a regulated environment is desirable.

Preferred Skills

• The Ideal Candidate Minimum 10 years’ experience supporting Computer System Validation on Systems Integration Projects and System Development Lifecycle (SDLC) and Data Integrity requirements.
• Knowledge of 21CFR Part 11 requirements, ER/ES and data integrity guidelines is desirable.
• Strong oral and written communication skills are required, with proven ability to communicate and build relationships cross-functionally.
• Self-motivated, detail-oriented, and excellent organizational and time management skills.

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