The Denzel Group is partnered with a growing Life Science company that has an urgent need for an IT Validation Lead with SAP experience. This is a long-term contract position that we can offer a very competitive rate for.
Minimum of ten years of experience in performing validations of computerized systems in the Life Sciences industry.
Experience as a validation resource for a minimum of two SAP implementations in a manufacturing environment.
Vast Knowledge of GXP (Good Manufacturing/Clinical Practices), GAMP, CFR 21 Part 11 and ICH & ISO Standards.
Experience as the Validation Lead role for a global SAP implementation in the Life Sciences industry that included a release to production, data migration, interfaces with manufacturing and execution system and laboratory system.
Experience in writing/providing content for the standard validation deliverables for a system implementation like Validation Plan, Requirement Specification, Traceability matrix, Test Summary report and Validation Summary report.
Experienced in creating and presenting quality and test metrics/reports to the business partners and senior management team.
Experience in working with system integrator resources off-shore and on-shore, managing relationships with business process owners, system owner, solution team to ensure the total validation/verification/qualification solution delivered meets/exceeds expectations. Ensuring SDLC/CSV/Qualification activities are conducted in a cost effective manner.
it validation, sap, validation, gxp, gmp, computer systems validation, csv, validation specialist, validation analyst, validation engineer, sap validation