Responsabilitati si beneficii:

As Assistant/Consultant in QA & Validation, you assess suppliers of Computerized Systems and related IT services (from the quality point of view) to ensure the appropriate quality and reliability of a given product and/or service supplied during its entire lifecycle.
The client is one of the global Biopharmaceutical leaders focused on severe diseases.

Responsibilities & duties

▌Responsibility 1

Support the supplier assessment activities:

 Collaborate with IT and Business Departments in order to obtain the required information, related with their experience with the supplier and its provided product/service;
 Find the appropriate person from the supplier to answer questions;
 Contact supplier and explain the purpose of the supplier assessment;
 Submit appropriate questionnaire to supplier based on risk profile;
 Pursue supplier to ensure retrieve back of complete questionnaire;

 Perform first quality check of questionnaire and review additional document if provided;
 Organize meeting with supplier to review unclear answers;
 Take decisions according with the collected evidences (desktop review, additional discussion with the supplier, action plan, audit, etc.);
 Prepare for regulatory and customer audits and inspections and assist the validation related matters during audits and inspections;
 Add the collected evidences and written reports in the repository and update the internal supplier list.

▌Responsibility 2 (on request)

Support the Computerized System Validation (CSV) activities as Assistant in Computerized System Validation:

 Active involvement in the elaboration, review and approval follow-up of validation documents: Specifications, Risk Assessment, Validation Plan, Validation Reports and Periodic Review;
 Actively participate with system or process owners in problem solving during the validation challenging proposals, in looking for solutions, in making links to the different Quality Assurance processes; handle support escalations;
 Prepare for regulatory and customer audits and inspections and assist the department of Validation & Testing related matters during audits and inspections;
 Collaborate with several Experts Team, Quality Assurance, IT Governance and Business key users and project managers to ensure delivery of high quality computerized systems which are fit for purpose;
 Assess regulatory risk associated with computer systems and provide guidance on the management and mitigation of risk;
 Ensure compliance to customer quality requirements;
 Acquire a complete and detailed understanding of business logic behind individual requirements

▌Work standard – Provide agreed deliverables for the supplier assessment on time according to project planning