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.