Computerized Systems Validation Lead

Essential Requirements:
At least 5 years of experience as a CSV expert in Pharma/Life Science environment or equivalent highly regulated industry;
Advanced knowledge of GxP, 21 CFR Part 11, EU Annex 11, GAMP5 and Data integrity principles;
High interest towards Digital Transformation, Process Improvement, Operational Excellence;
Demonstrates a high level of subject matter expertise in functional areas to bridge business requirements and IT solutions;
Demonstrates experience in process improvements designing and building complex testing tasks, understands the business process design;
Proactively initiate, develop and maintain effective working relationships within the company, demonstrated ability to cooperate with a variety of people through the organization;
Experience and capability to handle multiple projects in parrallel;
Design Thinking;
High attention to details;
Proactive attitude and curious learner;
Willing to deliver highest quality;
Very good analytical skills;
Result oriented;
Adaptable and fast learner;
Very good level of English (spoken and written).

Descrierea jobului
Role Summary:
Responsible for the whole CSV strategy and activities according to expected results and industry best practices, ︁︈​︂︁︉​︁︈​︂︃︈and their delivery in line with deadlines. In addition, will participate to the department effort regarding IT support to internal users and data integrity governance.

Responsibilities:
Provides technical direction and ensures adoption of best-practice solutions;
Translates business requirements into functional requirements;
Ensures correct risk assessment of the requirements;
Proposes suitable design, both flexible and compliant with regulations;
Supervises testing activities;
Ensures that testing activities are being conducted in accordance to the testing strategy and plan;
Ensures test execution is performed according to the industry best practices;
Contributes to test effort estimation;
Prepares working instructions for tested operations;
Offers support to system users;
Executes ad-hoc activities upon request;
Coordinates with all team members, including 3rd party suppliers.
Responsible for all CSV questions raised during internal, external and regulatory audits.