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Quality Assurance Officer

Quality Assurance Officer

ErgomedMadrid, Madrid, Spain
Hace más de 30 días
Descripción del trabajo

Role and Responsibilities

  • The Quality Officer will support all audit activities within PrimeVigilance and will work with the Auditing team and Quality team s to ensure audits are delivered in line with PrimeVigilance and procedures and global regulations.

The Quality Officer will perform all activities described including but not limited to :

  • Audit Support :

    • Supports PrimeVigilance functional teams during the preaudit audit and postaudit stages for audits by clients or by PrimeVigilance internal QA function

  • Hosts onsite and remote audits
  • Provides support for regulatory inspections of clients
  • Assists in scheduling client requests for audits / inspection support
  • Administrative support

    • Supports Quality in the tracking of audit status and deliverables

  • Metrics and Key Performance Indicators

    • Supports Quality in the compilation and reporting of metrics and KPIs

  • Collects and collates data from systems and sources
  • Authors reports and summaries
  • CAPA Support Activities

    • Supports Quality in the tracking of Deviations and CAPAs

  • Facilitates CAPA response and resolution
  • Inputs data into the global audit CAPA tracker
  • Other Supportive Responsibilities :

    • Supports Controlled Document preparation by reviewing draft documents e.g. SOPs OGs

  • Supports the PrimeVigilance Senior Leadership team as needed.
  • Supports other Quality activities as needed.

    • Qualifications :

  • University degree in Biomedical sciences Natural sciences or Health Sciences is required : Pharmacy or BS / Masters degree in a scientific discipline Nursing or equivalent advanced degree with pharmaceutical industry experience. Or equivalent pharmaceutical industry experience.
  • Previous experience in the pharmaceutical and / or regulated industry in a quality setting preferably in Pharmaceuticals or Healthcare
  • Thorough understanding of the principles of Quality Assurance
  • Knowledge of national regulations and guidance related to Pharmacovigilance and Medical Information
  • Experience of participating in audits and inspections
  • Excellent communication and facilitation skills within a global organization
  • Proactive and selfmotivated
  • Advanced knowledge of English

    • Additional Information :

    We prioritize diversity equity and inclusion by creating an equal opportunities workplace and a humancentric environment where people of all cultural backgrounds genders and ages can contribute and grow.

    To succeed we must work together with a human first approach. Why Because our people are our greatest strength leading to our continued success on improving the lives of those around us.

    We offer :

  • Training and career development opportunities internally
  • Strong emphasis on personal and professional growth
  • Friendly supportive working environment
  • Opportunity to work with colleagues based all over the world with English as the companylanguage

    • Our core values are key to how we operate and if you feel they resonate with you then PrimeVigilance could be a great company to join!

  • Quality
  • Integrity & Trust
  • Drive & Passion
  • Agility & Responsiveness
  • Belonging
  • Collaborative Partnerships

    • Come and join us in this exciting journey to make a positive impact in patients lives. We look forward to welcoming your application!

    Remote Work : Employment Type :

    Fulltime

    Key Skills

    Graphic Designing,Information Technology Sales,IT Services,Accounts,Auto Parts,Import & Export

    Experience : years

    Vacancy : 1

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    Quality Assurance Officer • Madrid, Madrid, Spain