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Coordinate and maintain the Quality Management System (QMS).
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Ensure full compliance with EU GDP (Good Distribution Practice) guidelines and local regulatory requirements.
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Oversee quality systems, including CAPA, deviations, complaints, change control, and internal/external audits.
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Coordinate and execute product recalls.
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Approve and monitor suppliers, customers, and service providers.
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Support in regulatory inspections and licensing requirements.
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Lead training activities for staff and ensure continuous quality awareness.
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Read/download products temperature data and report it to the Authorities/principals/ customers or where applicable.
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Act as the official backup to the RPPV, ensuring compliance with pharmacovigilance obligations during their absence.
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Ensure compliance with national and EU pharmacovigilance legislation.
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Serve as 24/7 backup contact point for pharmacovigilance/quality issues.
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Ensure appropriate management and processing of all product quality complaints, individual case reports, medical or safety queries received.
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Ensure case reconciliation with all internal external partners as appropriate.
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Manage the preparation and implementation of local risk minimisation measures as required.
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Handle the review, approval, distribution, withdrawal of promotional and educational materials.
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Act as liaison with Authorities and principal companies regarding quality/PV matters.
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Keep archives/records updated.
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Be member of company’s Business Continuity Crisis Team.
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Act as one of the company’s First Aider (if needed).
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Act as Backup Health & Safety Responsible Person and be member of company’s Health& Safety Committee.
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Attend mandatory training to be able to fulfil his/her responsibilities.
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Degree in Life Sciences (e.g., Biology, Pharmacy, Chemistry etc.). A postgraduate degree will be considered an asset.
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Experience in the field of pharmaceutical industry and particularly in the field of quality/pharmacovigilance will be considered an asset.
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Demonstrated understanding of GxP, particularly Good Distribution Practices (GDP), Good Manufacturing Practices (GMP) and Good Pharmacovigilance Practices (GVP), will be considered an asset.
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Excellent command of the English language, both written and oral.
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Strong IT skills (e.g., Microsoft Office).
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Strong ethical standards and regulatory integrity.
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Analytical thinker with high attention to detail.
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Highly organized and deadline-driven; able to prioritize tasks and manage time efficiently in high-pressure environments.
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Capable of managing confidential data responsibly.
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Collaborative team player.
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Flexible and responsive under pressure.