QA Officer I

Orion Group Life Sciences are looking for a QA Officer I for our Multinational Pharmaceutical client based in Boxmeer. Initial 6-month contract. This is a fully onsite position.

The team

The QA Officer Level 1 is a position within the Center of Excellence Quality Operations (CoE QO). The CoE QO comprises various departments established to ensure that production activities are carried out in compliance with applicable Good Manufacturing Practices (cGMP). These activities encompass the production, receipt, storage, testing, processing, release, packaging, labeling, and distribution of products throughout their shelf life.
The QA Officer Level 1 is part of the QA-IPT or CoE department and works closely with the Qualified Person within the QA-IPT or CoE, Operational Coaches and (Senior) Operators from the relevant IPT, as well as IPT-Improvement. The QA Officer reports to the QA-IPT Lead.

Main Responsibilities of the role

• Advising on, supporting, and approving equipment installation, qualification, and validation.
  • Support qualification and validation activities as a subject matter expert in quality.
  • Review and approve qualification/validation protocols and reports.
• Advising on and supporting root cause investigations and approving documented investigations regarding deviations.
  • Support root cause analyses in the event of deviations.
  • Inform or involve the Qualified Person or QA specialist regarding deviations with a potential impact on product quality, product safety, or compliance.
  • Approve root cause investigations and associated conclusions.
  • Approve corrective and preventive actions (CAPAs).
  • Review and approve changes.
• Reviewing and approving standard production documentation and protocols.
  • Review and approve master batch records for batch production and batch filling instructions.
• These responsibilities ensure that the product is manufactured in accordance with GMP requirements, internal quality standards, and the registration documentation.

Required Qualifications and skills

• Higher professional education (HBO) degree, preferably in Life Sciences or Pharmaceutical Sciences.
• Solid knowledge of GMP.
• Experience with Deviations, CAPA’s, Root Cause Investigations in the pharmaceutical/ chemical industry or government drug-regulatory agency.
• Experience with Validation, Qualification and Document Review in the pharmaceutical/ chemical industry or government drug-regulatory agency.
• Willingness to support change.
• Knowledge of and experience with biological and/or pharmaceutical-chemical production processes.
• Excellent command of Dutch and English.
• Effective communication and interpersonal skills.

If you would like to have a confidential conversation regarding this opportunity, please reach out to Tim Browaeys, [email removed] or contact Tim on [phone removed]

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