Pharmacovigilance Lead Auditor
1 day ago
We are looking for a skilled Pharmacovigilance auditor to join our Global Quality function at ALK-Abelló A/S.
Job DescriptionThe role of the Pharmacovigilance Lead Auditor is to perform PV audits internally at the ALK Headquarter and ALK Affiliates, as well as audits of external collaborators, service providers, and distributors. The ideal candidate will have experience in pharmacovigilance regulated areas and quality management systems.
About the Role- Performing PV audits as Lead auditor, on your own, and in collaboration with other PV and GDP Lead Auditors in ALK.
- Planning, execution, reporting, and CAPA follow up.
- Supplier Management, qualification of external collaborators, service providers, and distributors.
We are seeking a highly motivated individual with strong drive and ability to take own initiatives. The ideal candidate will have excellent verbal and written communication skills in Danish and English, as well as strong cross-cultural communication skills.
Your Profile- Bachelor's or Master's degree in Health Science with 5+ years of experience within pharmacovigilance regulated areas.
- Experience as Lead Auditor within PV performing internal audits and audits of external collaborators (distributors and service providers) and ability to start directly in a PV Lead Auditor position.
- Excellent knowledge of quality management systems and tools.
At ALK-Abelló A/S, we provide an attractive working environment for individuals looking for both personal and professional development. We are driven by a high level of professionalism, integrity, an open-minded approach, and contributing to an inspiring and fun working environment together with our colleagues.
Our offices in Denmark offer a green view of the surrounding area, and we believe that physical presence enforces strong teamwork and collaboration and creates success. We encourage you to visit us to learn more about our company culture and values.
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