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QA Process Reviewer

  1. Antwerp
  1. Contract
  1. Compliance / Quality Assurance
Date Posted25 Mar 2021
Our global bio-pharmaceutical client is seeking the expertise of a QA Process Reviewer (Quality Assurance) to support their state-of-the-art facility in Belgium. The department is responsible for guaranteeing the quality of the production process with a special focus on Technical Services activities and ensuring that it is in line with the prescribed procedures, standards, business practices and legislation.

  • Follow up, review & handle TS related issues (quality events, CAPAs, changes) so that they are completed compliantly and timely.
  • Follow-up, review & handling of environmental excursions (EEX) so that they are concluded compliant and timely.
  • Review of trend reports, alarms, risk assessments, procedures, etc. with regard to EM & utilities.
  • Reading and interpreting documentation regarding current and new compliance standards and regulatory trends and actions.
  • Participate in internal & external audits and inspections.
  • Involvement in any QA and interdepartmental project initiatives.
  • Support with problem solving meetings regarding TS / contamination control related topics.
  • Bachelor or Master's in a scientific direction or equivalent through experience.
  • Experience HVAC & utilities (WFI, CST, ROW, etc.).
  • Basic knowledge and interpretation of cGLP / cGMP / cGCPs in a regulated environment.
  • Excellent accuracy and attention to detail.
  • Independence and a strong sense of responsibility.
  • Interpersonal skills, an enthusiastic team player.
  • Good writing skills.
  • Good knowledge of the English language.

If you would like to learn more about this exciting opportunity, please apply today.

The candidate must have the rights to work in the location stated in the job advert.

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