Description
We are looking for Computer System Validation Lead / Consultant for a long term projectLocations: Copenhagen, Denmark
Language- English
Start- ASAP
Job Description:
Computer System Validation Lead / Consultant
Must-Have
1. Hands-On experience of CSV implementation with involvement in Installation/Operation
Qualification/Performance Qualification, protocol development/writing & execution in GxP
environment
2. Good understanding /exposure to FDA regulations /Global healthcare regulations for
Pharma, Regulatory Compliance, CFR Part 11 Compliance, EU guidelines, alignment to GAMP5
3. Experience in creating and executing infrastructure qualification protocols
4. Complete understanding of end to end CSV Process and Artefacts
5. Handson experience of working on Document Management and Test Management tools
Good-to-Have
1. Testing and Test Management Skills
2. Validation test scripts creation, review, and execution
3. Good documentation skills in writing Test Plan, Compliance Plan, User Requirement
Specification, Technical Design Specification, Functional Specification, User Work Instruction
, and Traceability Matrix
4. Good written and verbal communication skills. Confident about his area, concept, application
of the same, constraints, and ability to clearly and explicitly put the point of opinion to the customer
and the client stakeholders.
5. Leadership skills to drive himself/herself as a lead tester and QA validation
Responsibility of / Expectations from the Role:
1 Guide the application team for all the required CSV validation for different activities.
2 Creating validation documents from GxP relevance as per SOPs
3 Review all validation documents prepared by the application team and provide feedback on time, follow-up for the required
approvals.
4 Deployment of applications in a validated state
5 Identifying the gaps in the SOPs and updating/reviewing the organization SOPs from GxP relevance
Eligible candidates, please share their CV at / /
Regards
CosMicIT