Pharmacovigilance Lead Auditor Opportunity for Global Quality Expert
1 day ago
About ALK-Abello
ALK-Abello is a global pharmaceutical company specializing in allergy immunotherapy. We are driven by professionalism, integrity, and an open-minded approach. Our team values skill and knowledge creation, and we strive to make a difference for people with allergies.
Job Description: Pharmacovigilance Lead Auditor
We are seeking a highly experienced Pharmacovigilance Lead Auditor to join our Global Quality function. As a key member of our team, you will be responsible for performing PV audits, planning and executing audit activities, reporting findings, and ensuring timely CAPA follow-up. Your expertise will also be essential in supplier management, qualification of external collaborators, service providers, and distributors.
Key Responsibilities:
- Performing PV audits as Lead Auditor, both independently and in collaboration with other PV and GDP Lead Auditors.
- Planning, execution, reporting, and CAPA follow-up.
- Supplier Management, qualification of external collaborators, service providers, and distributors.
Requirements and Qualifications:
To succeed in this role, you will need:
- Experience as Lead Auditor within PV, performing internal audits and audits of external collaborators (distributors and service providers), with the ability to start directly in a PV Lead Auditor position.
- Bachelor's or Master's degree in Health Science with 5+ years of experience within pharmacovigilance regulated areas, including experience with quality management systems and tools.
- Experience with audits within other GxP areas is an advantage.
Personal Characteristics:
- Strong drive, takes own initiatives, and proactive action.
- Ability to work independently, but also a strong team player.
- Relation builder, working respectfully across different cultures with flexibility.
- Excellent verbal and written communication skills in English.
- Strong cross-cultural communication skills, both verbally and in writing.
What We Offer:
At ALK-Abello, we provide an attractive working environment for individuals looking for both personal and professional development. You will be part of an engaged and informal team that values skill and knowledge creation. The result of your efforts will be significant throughout the organization, and you will be able to actively influence and challenge the status quo.
How to Apply:
Apply by attaching your CV and a short letter of motivation. We commit to an inclusive recruitment process and equality of opportunity for all job applicants.
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