Quality & Compliance Officer BeNeSca
Il y a 4 heures
Gingelom, Flanders, Belgique
Vetoquinol
Temps plein
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pWe’re a top-10 global animal health company with a family business mindset. /ppEvery day, we make life better for pets, their owners and the veterinary teams who care for them. /ph3Job Description /h3pbWhat you’ll do /b /ppAs Quality Compliance Officer BeNeSca, you'll act as the local expert for quality and compliance while collaborating with colleagues across multiple functions and countries. /ppb1. Quality Management Compliance /b /ppAs the primary local quality contact and Responsible Person for Quality Assurance, you will maintain the Quality Management System and oversee day-to-day quality operations across the affiliate. /pulliEnsure all affiliate operations comply with applicable GDP requirements, local regulations and company quality standards. /liliMaintain and continuously improve the local Quality Management System. /liliManage deviations, change controls and corrective and preventive actions (CAPAs). /liliCoordinate self-inspections, support audit readiness and ensure inspection and recall preparedness for veterinary medicinal products. /liliSupport and oversee administrative batch release activities in accordance with applicable procedures. /liliManage product and customer quality data and ensure the effective handling of customer complaints, including logistics, commercial and quality-related complaints. /liliEvaluate and decide on the disposition of returned, rejected or potentially falsified veterinary medicinal products, escalating product quality concerns to Group Quality where appropriate. /liliSupport commercial teams by providing quality-related expertise and information that contributes to customer satisfaction and business objectives. /liliEnsure training programmes are implemented and promote a strong culture of quality and compliance throughout the affiliate. /liliStay informed about local and European GDP developments and regulatory requirements. /li /ulpb2. Health, Safety Environment (HSE) /b /ppYou will act as the local lead for Health, Safety Environment activities and contribute to a safe and environmentally responsible workplace in close collaboration with internal stakeholders. /pulliEnsure compliance with HSE policies, procedures and legal requirements. /liliIdentify, assess and report workplace hazards, risks, incidents and near misses. /liliPromote a strong safety culture and act as a role model for safe and environmentally responsible behaviours. /liliParticipate in HSE training, audits, inspections and corrective action programmes. /liliContribute to achieving the company's HSE objectives and sustainability goals. /li /ulpb3. Pharmacovigilance support /b /ppYou will support the Regulatory Affairs Pharmacovigilance Officer in maintaining a robust and compliant Pharmacovigilance system and contributing to Pharmacovigilance activities across the affiliate. /pulliContribute to the establishment, maintenance and continuous improvement of the affiliate's Pharmacovigilance Quality Management System. /liliSupport the preparation and maintenance of Pharmacovigilance procedures and related quality documentation, including local PV SOPs. /liliAssist in the collection, documentation, assessment and reporting of adverse events and safety-related information in line with regulatory requirements and company procedures. /liliSupport the management of Pharmacovigilance deviations and the timely implementation of CAPAs. /liliAct as backup for Pharmacovigilance responsibilities and assume designated LRRP duties when required to ensure ongoing compliance. /liliSupport Pharmacovigilance interactions with national authorities and internal stakeholders where required. /li /ulpb4. Regulatory Affairs support /b /ppYou will provide backup support for Regulatory Affairs activities and contribute to maintaining regulatory compliance across the affiliate. /pulliAct as backup for the Regulatory Affairs Pharmacovigilance Officer and assume priority Regulatory Affairs responsibilities when required. /liliSupport the administrative management of marketing authorisations for veterinary medicines. /liliMaintain regulatory databases and product platforms, ensuring accurate and up-to-date information. /liliProvide regulatory guidance and support for promotional materials, marketing activities and related compliance reviews. /liliContribute to the harmonisation of regulatory, quality and pharmacovigilance processes, promoting an integrated approach across these functions. /li /ulh3Qualifications /h3pbWho you are /b /pulliMaster’s degree in Veterinary Medicine, Pharmacy, Life Sciences, Biomedical Sciences, Biology or a related scientific discipline. /liliExperience in Quality Assurance within the pharmaceutical, veterinary pharmaceutical or life sciences industry. /liliStrong understanding of quality systems, GDP requirements and compliance processes. /liliExcellent organisational and analytical skills with a strong attention to detail. /liliAble to work independently while building strong relationship