QA Systems Officer  Amsterdam • Prothya Biosolutions

Roles and responsibilities:

• Third party audits and inspections: Coordinating and managing audits conducted by third-party organizations. This may involve organization of those audits, reviewing audit reports, communicating findings to relevant stakeholders, compiling the response and CAPA plans to these audits and perform the follow up in the eQMS.
• Quality system documentation:
  • Keep up to date procedural documents for the QSE which fall under the responsibility of QA Systems External Oversight
  • Act as QA approver of procedural documents
• Quality Agreements: Coordinating the management of quality agreements by creating new quality agreements for new suppliers and keeping up to date the existing quality agreements, including taken into account the periodic review cycle of the quality agreements
• Complaint to Vendors: Handling complaints related to vendors requires investigating and resolving issues promptly to maintain product quality and customer satisfaction, managing the process of documenting, tracking, and resolving complaints in collaboration with vendors and internal teams.
• Supplier Management:
  • Perform the final QA review of the A&R records related to materials
  • Follow up the qualified status of the suppliers in the SAP system (QIR)
  • Review of URS for new materials.
  • Performing external audits, when qualified for this task.
• Internal Auditing: evaluating the effectiveness of the different Quality system elements by assisting or leading internal audits, including reporting and follow-up of these internal audits in the eQMS.

Your profile:

• Bachelor's degree in a relevant field (e.g., Quality Assurance, Regulatory Affairs, Life Sciences)
• >2 years proven experience in Quality agreements, Complaints, Supplier notifications, ….
• Strong knowledge of GMP and other relevant regulations
• Strong communication and interpersonal skills
• Ability to work independently and as part of a team
• Detail-oriented with a commitment to quality and accuracy
• Fluency in Dutch and English
• Availability for 32 - 40 hours per week

Acquisitie wordt niet op prijs gesteld. Prothya aanvaardt geen ongevraagde hulp van bureaus voor deze vacature. Toegestuurde cv's (in welke vorm dan ook) door bemiddelingsbureaus aan enige medewerker van Prothya zonder geldige schriftelijke zoekopdracht, worden gezien als eigendom van Prothya waarvoor op geen enkele wijze een vergoeding verschuldigd is.