GxP Compliance & Validation Manager

GxP Compliance & Validation Manager:

For one of our globally leading tech clients we are urgently looking for an experienced GxP Compliance & Validation Manager for a long contract based in Zaventem, Belgium

Its paying well and my client can interview asap!

Skills:

• Computer System Validation, IT Compliance Management
• Secondary skills- Validating Clinical systems andor clinical supplies andor Safety andor Manufacturing systems, CAPA Management, Periodic Review

Job Description:

• 6+ years' experience in Computer System Validation or Quality management or Business Analysis in GxP application area
• Has working experience in any one or two of the following domains - Clinical Development and Supply Chain, Drug Discovery, MES, QMS, LIMS, Data Integrity Platforms.
• Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC.
• Application of FDA guidance's and industry standards (i.e., GAMP)?.
• Strong understanding on 21 CFR Part 11 and Risk Based Approach with the ability to guide the project teams.
• Possesses strong communication skills to interact with business stake holders (Technology Leader, Project Manager, Business OwnerBusiness usersSME) and interpret business rules and requirementsand documents them for software development.
• Expertise in documentingguiding various SDLC Deliverables including Requirements Specification User Stories, Criticality Assessment, Test Plan, Design Documentation, Validation Plan, Risk Assessment, Validation StrategyTest Planning, ValidationTest Summary, Requirement Trace Matrix.
• Possesses strong communication skills to interact with business stake holders (Technology Leader, Project Manager, Business OwnerBusiness usersSME) and interpret business rules and requirementsand documents them for software development.
• Should be able to handle and guide multiple GxP projects
• Ability to work with project team to facilitate interaction between Project team and Business Stake holders.
• Ability to manage and provide guidancetrain the team on Policies, end to end SDLC Process, Procedure and Tools
• Trains the project team on the relevant procedures associated with different SDLC processes and Tools
• Strong in Project Management tools like JIRA
• Manage Project priorities based upon identified risks.
• Performs Periodic Review and manages Periodic Review process
• Manages CAPA and associated Deviations and Non-conformance(s)
• Works from office at least 2 or 3 days in a week.

If this is you, then please do not delay in applying!