Computer Systems Validation Consultant (Hyderabad)

Computer Systems Validation Consultant (Hyderabad)

13 Aug
|
Propharma Group
|
Hyderabad

13 Aug

Propharma Group

Hyderabad

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D; technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

This full-time, permanent Computer Systems Validation Consultant position is responsible for independently managing Computer System
Validation projects and providing consulting and contract services to clients. The consultant will support computer system validation activities
focusing primarily on authoring validation documents, verification test execution. and technical writing.





Essential Functions Include:
- Author Validation Plans and Test Plans
- Author User and 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 all technical, business, and qualified interpersonal levels of the organization.
- Apply Computer System Validation experience as it relates to GxP regulated business processes.
- Attend and contribute to scheduled CSV Practice meetings.
- Participate in company programs such as Project Management, Quality, Social Responsibility, Wellness, Safety, and Training.
- Obtain specific assignments from ProPharma Group or the client Project Manager.
- Ens

📌 Computer Systems Validation Consultant (Hyderabad)
🏢 Propharma Group
📍 Hyderabad

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