Computer Systems Validation Consultant
Hybrid · Hyderabad, Telangana, India
Job Summary
Independent management of Computer System Validation projects focusing on authoring validation documents, verification testing, and technical writing; author Validation Plans, Test Plans, and User/Functional Requirements Specifications; author qualification protocols (IQ/OQ/PQ) and associated Trace Matrices; execute qualification protocols (IQ/OQ/PQ), collect testing evidence and document deviations; author Part 11 and Annex 11 Compliance Reports; author Test Reports and Validation Reports; perform technical writing and communicate clearly on technical, business, and professional levels; apply Computer System Validation experience as it relates to GxP regulated business processes; participate in CSV Practice meetings; contribute to company programs (Project Management, Quality, Social Responsibility, Wellness, Safety, Training); obtain assignments from ProPharma Group or client Project Manager; ensure activities are communicated and documented to the Project Manager; create annual personal goals and development plans; assist with interviews of ProPharma Group candidates; other duties as assigned.
Required Qualifications
- B.S./B.A. in Engineering, Science, Information Technology, or related field
- Three years of relevant work experience
- Minimum 3 years experience in the field of Computer System Validation
- Minimum 3 years experience in related Pharmaceutical or Healthcare Industries
- Experience in the validation of at least two of the following computer system categories: clinical data/study management, automation control, laboratory systems, quality management systems, ERP, and medical device software
- Ability to quickly learn new software applications used in GxP activities
- Effective written and oral communication skills; ability to write, type, express or exchange ideas of a technical nature; convey information accurately
- Working knowledge of Microsoft Word and Microsoft Excel
- Basic knowledge of FDA GxPs, FDA Guidelines, European Guidelines and other regulatory requirements
- Basic knowledge of industry best practices such as GAMP5, ANSI standards (S-95, S-88), and ASTM (E2500)
- Basic knowledge of 21 CFR 11, including ERES, predicate rule and legacy system requirements
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