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Str Muresului nr 23 MUNICIPIUL CLUJ-NAPOCA, (Romania cu domiciliu in RO)

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Validation Assistant

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Descriere Job

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


Cerinte Job

Work experience & skills

Knowledge in Computerized System Validation (CSV) and computer compliance regulations 
Knowledge of the systems development lifecycle V-model
Excellent knowledge of MS office suite
Knowledge in Supplier Assessment for regulated system (GxP)
Expertise in preparing, running and monitoring projects

Personal qualities & behavioural traits

Methodical, well-organized, structured person
Ability to gather, summarize complex information from multiple internal and external sources
Be able to finalize in time the assessment process
Strong analytic thinking including analyse results, draw conclusions and make recommendations
Self-taught and a fast learner
Good ability to adapt to multicultural environments
Good communication and negotiations skills both in writing and verbally
Self-motivated with the ability to work proactively using own initiative
Strong technical writing skills for generating high quality protocols & technical reports
Highly customer focused and passionate about delivering excellent customer service
Ability to handle sensitive documents and information in strict confidence, as well to apply sound judgment in processing and interpreting data
Sharp attention to details

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