Validation Engineer- eCompliance
Reading Metro Area, Pennsylvania
Quality Engineering and Validation support to analyze and improve the manufacture of the various products in the facility
Facilitate/Review/audit and/or approve validation documents for computerized systems (e.g. user requirements, Validation Plans, GxP/ DI Risk-Assessment, test protocols, Validation Report, and GxP relevant changes and deviations).
Maintain and follow up on Validation Corrective Action Plans and Gaps identified from Data Integrity implementation.
Particpiate in Data Integrity asessments of APD equipment / systems.
Provide progress reports to management for computer system upgradesand Data Integrity initiatives.
Ensure that computerized systems activities are being carried out within the framework of local regulations and in accordance with all applicable Quality Modules and with the local requirements defined in SOPs.
CSV support to Manufacturing and ITin the development of new and upgraded processes
Co-ordination of the regional/local e-Compliance related activities.
- Computer System Validation (CSV) experience and knowledge of applicable e-Compliance regulations
- Preference will be given to candidates with prior experience within the medical device or pharmaceutical industry.
- Root cause analysis; data-driven decision making; and strong risk analysis skills. He or she must have a good understanding of quality regulations; strong computer skills; excellent written/verbal/communications; strong interpersonal skills; and must be able to perform in a fast-paced, team environment.
- Bachelor s Degree
- Excellent knowledge of English