Caguas, Puerto Rico
Computer System Validation Lead
PQE Group is a Contract Quality Organization and a Complete Quality Solution provider for GCP, GLP, GMP & GDP areas in the Life Science Industry. Since 1998, we have successfully completed more than 7,000 projects worldwide and now serve our Clients from offices in Italy, Spain, Switzerland, Germany, LATAM, USA, the Middle East, China, India and Japan. As an international group we have experience working in more than 25 languages and have an excellent history of supporting small, medium and large size companies exceeding compliance standards from the FDA / EMA / WHO / TGA / SFDA / ANVISA / INVIMA / GILS and other local authorities. PQE Group offers turnkey quality solutions and focuses on offering exceptional cost effectiveness, whilst maintaining highest quality standards for our Clients.
PQE is looking for a new Computer System Validation Lead willing to join one of our local project in the Caguas area (Puerto Rico).
- Ensure completeness and consistency of validation life cycle documentation for computerized systems used to control/monitor and manage data on laboratory and production environments
- Resolution of fundamental Computer System Validation (CSV) compliance issues derived from impossible implementation of 21 CFR Part 11 automated controls/functionalities in legacy systems
- Align with e‐Compliance on project management and life cycle documentation deliverables for GxP relevant projects
- Ensure all project related risks are well managed and deliverables are validated (for GxP)/tested (for non‐GxP) in accordance to SOP and the associated CSV requirements
- Ensure project team complies with the methodology and SOP and uses the correct tools
- Ensure all project related issues and deviations are recorded, approved and dispensed accordingly (including ensuring proper deviation report preparation and approval)
- Prepare project and life‐cycle reports and review/approve all other documents to ensure compliance with SOP
- Ensure all project and lifecycle documents achieve the goal of traceability, and these are all retained in document repository (Document Navigator) and approved in accordance to the prescribed SOP
- Above 10 years experience with Computer System Validation
- Development and review of computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, summary report)
- Supervision of protocols execution activities
- Excellent communication skills
- Ability to work as a team player in a consulting environment
- Able to manage direct relation with stakeholders and project team members
- Proactive approach
- English language proficiency
- Valid US work permit
- Full availability to travel (up to 70%) across Puerto Rico
If interested, please send your resume clicking the button on the left of this page.
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