IT Quality Lead (CSV)

Qualifications : - Providing the validation strategy for different computer systems in life sciences industry- Possess expertise in managing acquisitions and divestitures from a Computer System Validation (CSV) perspective.- Comprehensive understanding of the Computer System Validation process, particularly in relation to GxP applications and systems.- Capability to remediate CSV Validation documentation.- Strong understanding of CFR 21 Part 11 and the SDLC lifecycle related to validation requirements.- Ability to work within a team and independently.- Strong English communication and written skills requiredPreferred Qualifications : - Previous experience working for an Innovative Medicine company is preferred.In addition to validation and regulation experience, the resource should have the following experience : - Project Leader / Senior 3-7 years of relevant experience- Work independently and guide / mentor Junior resource- Experience in the Pharmaceutical, biotechnology, or medical device industry- 2 years' experience with System Development Lifecyle- 3 years' experience in Computer System Validation (Based on the role selected)- Experience in FDA and / or global regulated environment with good understanding of GxP standards and Risk based validation- Knowledge of FDA guidance's and industry standards (i.e., GAMP)- 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 reviewing system test and user acceptance test scripts, traceability matrix and design specs- Experience in QA Methodologies, designing, reviewing and approving test plans, systems and UAT test scripts and test procedures- Ability to work with remote teams and support several changes / projects simultaneously- Ability to provide validation guidance, timely reviews, and escalations to TQ management