Quality Officer - Pharmacovigilance

About us:

Qualifyze is a leading provider of supplier qualification solutions for the pharmaceutical industry. Our mission is to help healthcare companies ensure the quality and compliance of their supply chains. We do this mainly by organizing and executing audits at the suppliers and service providers of the pharmaceutical industry.

By the end of 2023, we had conducted almost 2500 audits to manufacturers of APIs, Finished Dosage Forms, Pharmaceutical excipients, Medical Devices, and providers of services related to Distribution, Subcontracted testing, Clinical trials and Pharmacovigilance. But we aspire to much more! Our mission is to collect actionable audit data from every supplier in the world, centralised within our digital platform, and to turn this data into powerful tools to enhance the management of suppliers in the industry, and beyond!

In order to continue breaking our records and pursuing our ambitious targets, we are looking for a Quality Officer to join the Audits management team, within the larger Quality department. Members of this team play a critical role in ensuring that our audits and reports are always exceeding our stakeholders' expectations.

Main responsibilities

• Ensure that our services meet all the necessary requirements before they reach the consumer.
• Perform accurate audit preparation to provide the related documentation to the auditor and the audited companies
• Oversee audit reports (mostly from PV audits) to identify deviations from quality standards to make sure it has been built with compliance with the applicable standards and meets customers’ expectations
• Co-supervise auditor’s performance and provide guidance and feedback
• Participate in audits (specifically in PV) as auditor/co-auditor/observer
• Participate on the lookout for opportunities for improvement
• Participate on the definition of Qualifyze’s “common voice” related to technical aspects

Education

• Degree in pharmacy, chemistry, biology, or a related field with a strong foundation in science/healthcare

Skills

• GxP knowledge, specifically GVP
• Open and communicative
• Fluent English communication skills in written and spoken (other languages are appreciated as well)
• High computer and tech affinity
• MS Office skills
• Professional behavior in front of the client, auditors, and teammates
  Interesting add-ons: GCP and GMP knowledge