*Hi,* *This is Patrick* ** *Validation Lead- ePedigree / Serialization - Life Sciences Domain *
- 8+ years experience in Quality and Compliance with substantial hands-on computer system validation experience - Prior experience leading/mentoring other validation professionals - Prior experience working with offshore teams - Experience in FDA regulated environment with good understanding of GxP related processes including Risk Based validation. - Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs. - Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, - Test Summary reports and Compliance/validation reports. - Experience in Software Development Lifecycle (SDLC). - Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures. - Experience with in Change Control processes. - Experience with various FDA regulations (e.g. 21 CFR Part 11, 210, 211, 820) - Experience is creation of SOPs. - Knowledge of FDA guidance’s and industry standards (i.e., GAMP) - Hands on experience in HP Quality Center and QTP. - Strong verbal and written communication skills. - Perform assessments of computer systems and processes at client sites (compliance with internal procedures, industry best practices, and regulatory requirements) - Develop validation strategy documents, write user requirements, SOPs, IQ/OQ/PQ, and create validation summary reports *Thanks & Regards* *Patrick* *Technical Recruiter* *Phone: 201-731-2034 X 942 * *Email: **[email protected]*<[email protected]> ** -- You received this message because you are subscribed to the Google Groups "American Vendor--IT Consulting" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send email to [email protected]. Visit this group at http://groups.google.com/group/sap-vendor. For more options, visit https://groups.google.com/groups/opt_out.
