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Pharmacovigilance Quality Auditor(m/w/x)

Merck KGaA
Darmstadt

You oversee and conduct various quality audits in pharmacovigilance, ensuring compliance with regulations while managing data analysis and special projects for ongoing improvement.

Anforderungen

  • •3-5 years auditing experience
  • •Demonstrated knowledge of Quality Assurance
  • •Working knowledge of GVP and ICH regulations
  • •Strong structured work ability
  • •Team player with excellent communication skills
  • •User knowledge in PowerBI and MS Office 365
  • •Excellent communication skills in English
  • •Willingness to travel globally

Deine Aufgaben

  • •Lead and coordinate quality audits globally.
  • •Participate in on-site and remote audits.
  • •Conduct vendor and process audits.
  • •Perform data analytics during preparation.
  • •Prepare standardized audit plans.
  • •Create and present audit reports.
  • •Follow up on audit observations.
  • •Manage special projects for quality improvement.

Deine Vorteile

Diverse backgrounds and perspectives
Commitment to excellence and innovation
Access and growth opportunities
Culture of inclusion and belonging

Original Beschreibung

We are experiencing a technical issue with the Careers Website. At the moment, applications are not possible. We are working on resolving the issue as soon as possible. Thank you for your patience. # Pharmacovigilance Quality Auditor (all genders) Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe. **Your role:** We're seeking highly motivated and self-starting individuals to join our diverse and very engaged quality auditing team! We offer a quality auditing function, with good visibility into our Research & Development function and close interaction with various stakeholders. In this role you lead, coordinate, and participate in the organization and execution of quality audits of different types (on-site or remote subsidiary/affiliate audits, vendor audits, process audits and business partner audits) in the pharmacovigilance area globally. You perform data analytics during the preparation phase, prepare meaningful, standardized audit plans, create audit reports, and present audit observations and follow up on those. Further, you will be taking over individual special projects to support the continuous improvement of the quality auditing function and to ensure audits are conducted consistently to high quality and in accordance with international and local Pharmacovigilance regulations and guidelines. **Who you are:** * Minimum 3-5 years auditing experience in pharmacovigilance quality management and/or systems * Comprehensive demonstrated working knowledge of principles and concepts of Quality Assurance and auditing skills covering a broad range of areas with focus on pharmacovigilance and preferable additional GxP areas * Working knowledge of GVP, ICH, US FDA and EMA regulations * Strong ability to work in a structured way: good planning, project management and organization skills, track record of meeting milestone deliveries under tight deadlines and having a service-minded but goal-oriented mindset. * Team player with very good intercultural and excellent communication skills; respectful interaction with auditees, independent, motivated, responsible approach to work * User knowledge in PowerBI, MS Office 365, Veeva Vault QMS * Excellent oral and written communication skills in English and ideally one other language * Willingness to travel globally (up to 15% travel time) **What we offer:** We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Job Requisition ID: 290195 Location: Darmstadt Career Level: D - Professional (4-9 years) Working time model: Full-time **North America Disclosure** The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request.  You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance. **Notice on Fraudulent Job Offers** Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information. **Job Segment:** R&D, Pharmacovigilance, QA, Quality Assurance, Project Manager, Research, Healthcare, Technology, Quality
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