SAS/Contamination Control

Amsterdam  ‐ Onsite

Description

Sterility Assurance Specialist/Contamination Control

50% On Site and 50% Remote

4 months

Start asap

Responsibilities:
  • Assessing processes, systems, and equipment in the field of sterility assurance.
  • Establishing the Contamination Control Strategy (CCS).
  • Providing counsel to the organization on product sterility and contamination control.
  • Evaluating the ramifications of deviations that may jeopardize product sterility.
  • Leading cross-functional projects within this specialized domain.


Requirements:
  • Profound understanding of microbiology is indispensable.
  • Experience with implementing EU requirements outlined in Annex I, including the development of a contamination control strategy.
  • Ability to establish and lead the Contamination Control Board.
  • Supporting microbial assurance aspects of the Quality System.
  • Coordinating the utilization of all microbial services.
  • Contributing to the review and enhancement of procedures related to microbial assurance activities.
  • Implementing GMP training programs for clean room and relevant staff.
  • Assisting the Quality team in audit preparation and execution as a Subject Matter Expert in Contamination Control.
  • Thorough comprehension of the legal and regulatory framework concerning Sterilization and Environmental monitoring.
  • Demonstrating a proactive approach and strong teamwork skills.
  • Proficient in communication, preferably in both Dutch and English.
  • Experience in conducting GMP audits, both internal and external.


Please send your CV to

Darwin Recruitment is acting as an Employment Business in relation to this vacancy.
Start date
05/2024
Duration
4 months
From
Darwin Recruitment
Published at
08.05.2024
Project ID:
2748141
Contract type
Freelance
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