QA Operational Readiness Officer - #50799

Pauwels Consulting


Datum: 17 uur geleden
Stad: Geel, Vlaanderen
Contracttype: Voltijd
Our client, a leading life sciences organization, is seeking a QA Operational Readiness Officer to support the start-up of a new production facility. The role focuses on providing comprehensive quality documentation review and hands-on operational support during the facility qualification and start-up phase.

Responsibilities

  • Review and approve quality documentation including preventive maintenance plans, SOPs, and qualification protocols (DQ, IQ, OQ, PQ).
  • Author risk assessments for new processes, equipment, and procedural changes using structured methodologies.
  • Perform gap analyses between draft documents and GMP requirements or regulatory expectations.
  • Provide quality support on the shop floor during manufacturing and engineering qualification activities and first production runs.
  • Assist in quality event investigations, including deviations, non-conformances, and out-of-specification results.
  • Manage change control activities and update QMS documentation in line with site procedures.

Requirements

  • You have a Bachelor’s degree in Life Sciences, Engineering, or Quality Management.
  • You bring 1+ years of experience in pharmaceutical or biotech quality assurance or a relevant internship in a GMP environment.
  • You possess a foundational understanding of risk management principles and technical document authoring.
  • You have strong attention to detail and the ability to identify gaps or inconsistencies in documentation.
  • You’re a proactive communicator who is comfortable supporting cross-functional teams in a fast-paced environment.
  • You are fluent in English.

Nice to Haves

  • Familiarity with GMP documentation principles and quality systems.
  • Experience with FMEA, HACCP, or eMBR templates.

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