QA & Training Technician - Madrid, España - Pivotal

Pivotal

Empresa verificada

Madrid, España

hace 2 semanas

Publicado por:

Isabel García

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Descripción

Pivotal's QA&C Unit has a vacant position for a QA & Training Compliance Technician (QACT), Europe (preferably based in Madrid Pivotal Office).

Responsibilities:

Support the Director, Quality Assurance and Compliance (QA&C) in Quality Assurance activities, assuring compliance with ICH/GCP standards and national/international regulations, both in processes and projects handled by Pivotal:

Quality Manual maintenance and tracking:
participating in the revision, updating and implementation of Policies and SOPs and supporting documents.

Ensure GCP compliance, assisting in promoting quality principles across the company, providing GCP advice to all staff involved in clinical study activities and providing input into process improvement initiatives across the company.

Provide support to Operational Departments in all GCP/Quality aspects as required.

Organize and participate in contracted audits as required (investigator sites, Trial Master Files, Clinical Databases, ICFs, etc.).

Support in preparing Sponsors' audits and inspections.

Tracking and follow up of issues (CAPA, SOP Deviation, Quality issue) until close-out. Raise significant issues of non-compliance, as needed.

Assist in providing internal trainings related to Quality aspects: Good Clinical Practices, Good Documentation Practices, Risk Management, Data Integrity, etc.

Support to Training department in the following the activities:
Annual Training Plan in agreement with all Company Area Managers.

Training matrix in agreement with all Company Area Managers

Maintain the Training Record File (TRF), creating training record forms and ensuring these forms are duly signed.

Organize and supervise contractors training.

Supervise that all training forms follow the guidelines described in the SOPs.

Verify training connections according to established SOPs.

Review all approved training requests and, in discussion with the Managers, schedule all appropriate training courses.

Participate in Risk Management Committees, ensuring that Quality aspects are raised and evaluated.

Collaborate with Product Owners in the design, and review of validation activities for electronic systems according to CFR21 part 11 and GAMP5 requirements including electronic signatures.

Ensure the maintenance of validated systems following Change Control processes, as requested.

Provide support in Vendor Evaluation and Qualification processes ensuring that the list of approved vendors is up to date and all critical vendors are identified and their performance monitored.

Qualifications / Skills:

High level of spoken and written English required.

Willingness to travel occasionally.

Experience in auditing and preparing inspections is desired.

Thorough understanding of ICH E6 GCP, applicable national/international regulations, and EMA/FDA requirements.

Flexibility and ability to investigate and analyze information, to draw conclusions and provide recommendations.

Detail-oriented, accurate and able to solve problems.

Ability to work in a structured and organized manner.

Enjoy working as part of a team and independently.

Education and Experience:

Life science University Degree.

Previous experience in clinical trials in CRO/Pharmaceutical company: at least 2 years previous experience in Quality Assurance department, and/or a minimum of 3 years' experience in clinical trials in different relevant functions.

Experience in international projects is highly recommended.

Ability to work effectively with clients and across internal departments.