Quality Assurance Specialist Πλήρης Απασχόληση

Medwork, the leading Pharmacovigilance service provider in Greece, is currently seeking to recruit a Quality Assurance Specialist (Code: QA)

Medwork is looking for a skilled QA expert with a strong interest in quality compliance to join its quality department.

The position includes responsibilities across GxP areas (mainly GVP and GCP) as well as involvement in quality assurance aspects of IT operations.

As part of the Quality Department, you will be expected to further foster a culture of quality, support the strategic direction of the quality management system (QMS) and ensure that the QMS is on a permanent track of improvement. In addition, you will be expected to support the QMS of selected clients operating in the pharmaceutical sector.

Key Responsibilities

• Involvement, consultancy and/or support in activities related to the maintenance and continual improvement of a quality management system, including but not limited to the following:Management of non-conformities/deviations and related corrective/preventive actions
• Management of changes
• Qualification and management of vendors
• Risk management
• Planning, conduct and/or management of internal audits and vendor audits
• Definition and assessment of quality objectives and KPIs
• Quality assurance aspects of IT operations
• Quality management responsibilities in the context of the quality systems (or parts of them) of client pharmaceutical companies (e.g. local companies, local affiliates of multinational companies), including but not limited to assuming specific functions on their behalf
• Consultancy and training on quality-related issues
• Development, review and update of procedural documents (e.g. policies, SOPs, work instructions)
• Development, improvement and monitoring of quality management systems according to defined standards (e.g. GVP, ISO 9001, elements of ISO 27001)
• Consultancy and/or coordination for audits and regulatory inspections (in the role of the auditee)

Key Requirements

• Previous experience in a pharmaceutical company or CRO
• At least 2 years of experience in Pharmacovigilance, Materiovigilance or Clinical Development, combined with at least 2 years’ experience in the Quality Assurance of relevant areas or
• At least 3 years of experience in Pharmaceutical Quality Assurance preferably in GVP or GCP
• Experience in GMP/GDP could also be considered
• Working knowledge of ICH and EMA/FDA regulations and guidelines and how these interface with other GxPs
• Knowledge of Drug Safety/Pharmacovigilance is advantageous
• Fluent in English
• Excellent computer skills

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