CSV Lead

As an IT Compliance Lead you will be in charge of the Validation and Compliance activities for the systems within your scope covering 3 key domains: SAP ERP GMP Lab Systems Patient Application (patient CRM Website Support Programs ). It includes leading the validation strategy for computerized system within this scope as well as maintaining and monitoring compliance level across the IT departments. You will also define and review IT Processes for your IT scope for compliance with policies and procedures.

Functionally reporting to the IT Compliance leads for each domain you will:

• Lead and manage the projects and validation activities from a budget planning & resource point of view.
  
• Establish and communicate the rules compliance standards guidelines for sustainable Compliance & Quality across the managed scope.
  
• Ensure that systems are audit ready; Present and defend the systems during internal or external audits / inspections.
  
• Provide support in addressing noncompliance situations and ensures that such cases are documented investigated resolved and/or mitigated (e.g.: CAPA management training compliance etc.).
  
• Responsible for all regulated activities and responsible to maintain the roadmap for a sustainable IT Compliance.
  

Requirements

For this role we re looking for the following education experience and skills

• Experience in Computer Systems Validation within a regulated environment with good knowledge of the GAMP5.
  
• Good knowledge of GMP and GCP and GPvP regulation specifically related to Validation of Computerized Systems Electronic Records & Electronic Signature (21 CFR Part 11 and Annex 11) Data Integrity and Pharmaceutical standards and their interpretation.
  
• Experience of 5 years in CSV domain in the Life Sciences (Pharmaceutical Medical Devices) and Healthcare industries.
  
• Knowledge of system development lifecycle (SDLC) processes.
  
• Experience with computerized testing processes and testing tools (e.g. ALM from Micro Focus/Open Text).
  
• Knowledge of the supporting processes: Change Incident Deviation Periodic Review processes.
  
• Experience in dealing with Regulators and Auditors preparation and/or inspection and audit defense
  
• Understanding of ERP and SAP systems: Understanding of SAP development approach is a real plus: Knowledge of at least one GxP SAP functional domain among the following: PPPI WM QM PM; Knowledge of SAP authorization and SAP Basis architecture.
  
• Fluent in English (spoken and written).