Our client is an international leader within contract development services within the biopharma space. To strengthen their lab in Belgium they are looking for a QP/QA Officer.
• To perform the Qualified Person (QP) function defined by Directive 2001/83/EC and Annex 16, with regards to Batch certification
• You will provide Quality Assurance expertise in driving operational activities associated with Global Clients
• For investigations/deviations/out-of-specifications audit observations associated with analytical activities in the laboratory, you will be the central QA point of contact
• Reviewing protocols, SOPs, summary reports, CAPA’s and internal specifications to ensure documentation accuracy and completeness
• You will be supportive of deviation investigation, retrieving and collecting supportive information to allow impact assessment and perform the review of testing documentation
• You will present quality issues, resolutions and drive quality performance at client meetings
• You will ensure monthly metrics are gathered and communicated in a timely way
• You will have a minimum of 6 years’ experience in the pharmaceutical Industry with operational GMP experience (Analytical QA/QC) an advantage
• You will be registered in Belgium to act as a QP
• Have extensive knowledge in the global pharmaceutical industry, including interpretation and practical application of applicable regulations and have a technical perspective
• Must be experienced with regulatory bodies and third-party organizations with respect to QA systems and regulatory inspection preparedness
• Must have high analytical capabilities and be customer-oriented
• Must be fluent in English & French – Dutch would be advantageous
Interested? Please do not hesitate in sending your CV and/or the best contact details for yourself to firstname.lastname@example.org and our team of skilled consultants would be very happy to contact you with more details.
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