Quality Management Associate (QEs and CAPAs)

  • Full-time
  • Department: PV QM

Company Description

PrimeVigilance, an Ergomed brand, was established to provide specialised pharmacovigilance services to pharmaceutical and biotechnology companies. These services cover the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects.

Job Description

Provides support and advice to all PrimeVigilance functional teams to ensure that the company’s quality management system (QMS) is established and maintained to the highest quality and that it is compliant with global regulations, legislation and PrimeVigilance requirements.

The Quality Management Associate (QEs and CAPAs) will be responsible for all activities involving the management of PrimeVigilance Quality Events (QEs) and Corrective and Preventative Actions (CAPAs).

Activities include, but are not limited to:

  • Supporting and advising PrimeVigilance functional teams in identifying, reporting and addressing Quality Events (QEs) and quality-related issues.
  • Supporting and advising PrimeVigilance functional teams in creating, managing and implementing CAPA plans.
  • Monitoring the progress of QEs and CAPAs in the workflow and ensuring that steps are completed within specified timelines.
  • Identifying and escalating serious and/or systemic issues to Quality Leadership Team.
  • Generating and distributing reports relating to QEs and CAPAs as required.

Qualifications

  • University degree in a Life Science or appropriate equivalent work experience.
  • Interest in Pharmacovigilance, Quality and Compliance is essential
  • Excellent skills in planning, organisation and communication.

Additional Information

  • Work within a successful, highly – qualified and dynamic team
  • Professional training and career development in a fast-growing healthcare company
  • Flexible working hours
  • Possibility to work from home
  • Meal allowance 
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