QC specialist

Brabant Wallon – contracting

Support GMP activities in the laboratory such as

• Change control creation and follow up
• Actions follow up
• Training matrix review and documentation
• Protocol, study execution and report for compendial feasibility
• Update/review of laboratory documentation: analytical methods; analytical instructions; coaching's modules,…
• Ensure follow-up and compliance of procedures and instructions, and update if needed.
• Ensure follow-up of corrective actions and preventive actions.
• Support product launches and prepare documentation requested by authorities
• Update of batches documentation according to specifications
• Support documentation linked to in process analyses

• Master's degree required in analytical chemistry ,biochemistry (HPLC, GC, IR, UV, Empower, etc) or equivalent
• Expertise in the pharmaceutical analysis for min. 5 years
• Experience in GMP
• Strong organization skills with proven records
• Proven project leadership skills including planning, monitoring, compendial verification with protocol and reports, decision making and reporting;
• Proven experience in documentation creation, update to support QC activity
• Ensure required corrective actions are taken and put in place and lead the implementation in collaboration with the QA, team leaders and technicians
• Understanding of all analytical disciplines related to CMC for late stage development and commercial products (analytical development, stability testing and quality control of drug substance, drug product, raw material and intermediate).

Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.

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