Computer System Validation- SAP
PharmEng Technology is currently seeking a Computer System Validation
assist our team for projects in Canada, ON. The position is available immediately conditional of a successful interview.
- Develop and execute computerized systems validation protocols (IQ/OQ/PQ). Validation Summary report, Data Transfer and Integrity Testing Protocol.
- Prepare validation documents: capture functional requirements for the client, change control, standard operating procedures (SOPs) and reports etc.
- Solve problems during validation process and address/advise on issues such as deficiencies, deviations and change control etc.
- Maintain personal training records. Ensure compliance with relevant regulations (e.g. cGMP/GLP/GAMP/GALP).
- Complete assigned projects and tasks within agreed deadlines.
- Assessment of client computer systems in terms of FDA 21CFR Part 11 compliance
- Review existing SOPs and prepare draft to serve as the framework for Computer System Validation Projects
- System Implementation ERP SAP
- Project Management methodology
- Recommended) Bachelor Degree and 3-5 years of validation experience or Masters Degree and 2-5 years of validation experience and biotechnology experience.
- Experience with SAP: SAP products, SDLC, ERP (Enterprise Resource Planning),
- Familiarity with applicable US and worldwide regulatory requirements for the biotechnology industry (i.e. GMP and GLP).
- Experience with Microsoft Word and Excel.
- Willingness to travel
- Hold a valid driving license and passport