Quality Assurance Technician

hace 16 horas

Madrid, España Pivotal A tiempo completo

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

Support D,QA&C in the maintenance of Quality Assurance system

Support D,QA&C in ensuring 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

Organize and participate in contracted audits as required (investigator sites, trial master files, database, ICFs, etc.)

Support D,QA&C in tracking and follow up of actions until close-out. Raise significant issues of non-compliance to D,Q&AC.

Support the D,QA&C in preparing sponsor audits and inspections

Support D,QA&C in keeping updated the Quality Manual. Keep tracking of Pivotal Quality Manual documents. Review, update and implement Quality Manual documents as necessary

Assist in provide internal trainings as required

Support D,QA&C in tracking SOP deviations and quality issues. Follow up corrective and preventive actions

Provide Quality Assurance support to company departments in all GCP activities as required.

**Required 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 organised manner

Enjoys working as part of a team and independently

**Education and Experience Requirements**:
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 6 years’ experience supervising clinical trials projects processes and procedures as LCRA or Project Manager

Experience in international projects is highly recommended

Ability to work effectively with clients and across internal departments

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