Job ID: 11672

Quality Assurance Validation Specialist (m/w/d)

Stellenart.

Festanstellung

Ihre Aufgaben.

The QA Validation Specialist is responsible for ensuring the compliance of our three sites in Germany, including its state-of-the-art storage and environmental monitoring systems. He or she serves has frequent contact with our customers in client audits as well as internal stakeholders on site.


What will you do?

  • Responsible of follow-up the inventory list of Equipment, Cold & Ambient Storage Rooms and ensure devices are maintained in a validated state.
  • Review and approval of validation documents (URS/ DQ/ RA/ IQ/ OQ/ PQ and Summary Report)
  • Review and approval of Re-Assessment/ Periodic Reviews (Equipment/ Cold & Ambient Storage Rooms)
  • Support, Initial quality review and approver during investigation/deviation/ CAPA
  • Gap analysis on current GMP requirements
  • Perform Risk Analysis according to SOP/ internal Requirements
  • Generation of re-qualification plans
  • Generation of corresponding qualification / validation documents
  • Creation, revision and updating of SOPs
  • Participation in client and regulatory audits and inspections

Ihr Anforderungsprofil.

  • Good knowledge of Validation/ Qualification (EU GMP Annexes 11, 15, ISPE, Cycle V, URS/DQ/IQ/OQ/PQ)
  • Education in Science or technical field (e.g. Bachelor or Master in Science or vocational training as laboratory technician, BTA, CTA, MTA, PTA or equivalent) is preferred
  • Several years of related experience in a GMP environment
  • High level of technical understanding in pharmaceutical or laboratory environment
  • Document writing skills
  • Good communication skills
  • Automation/ computer software validation experience is preferred
  • Business fluent in English.
  • German language is preferred
  • Ability to be a productive and supportive member of a project team, as well as working independently

Vorteile.

  • Employment within an innovative, growth-oriented organization.
  • Outstanding career and development prospects.
  • Company pension scheme and other fringe benefits.
  • Exciting company culture, which stands for integrity, intensity, involvement and innovation

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