Quality Assurance (QP) Officer

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.

Responsibilities

• 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

Requirements

• 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 info@thetechrg.com and our team of skilled consultants would be very happy to contact you with more details.

Proud to be working in partnership with Talentory AG

To apply for this job email your details to info@thetechrg.com

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