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