The companyOur client is a professional Pharmaceutical, Biotechnology and Clinical Research organisation, based in Flandre Orientale Belgium. The company is a leading organization for contract development and production for the pharmaceutical and biotechnology industry.
The company is recognized between four investment banks that offer additional expert services.
Within the Business Unit "Drug Development & Manufacturing" (DDM),
located in Ghent, we are looking for one
Role descriptionThe production officer supports GMP documentation (BRDs, deviations, modifications, CAPAs, SOP / WI, clean-up verification protocols / reports). The production officer carries out GMP production tasks (cleanroom, packaging and label).
ResponsibilitiesImplement GMP guidelines with documentation to production activities according to the current quality management system (documentation) and the provided training
Stay informed of the GMP Quality Management system. if necessary, switch the procedure documents.
Give input / suggestions about production related processes, efficiency, technical problems
Follow Good Documentation Practice when setting and using GMP batch record documentation
Report and document previous problems during the implementation of GMP production
Keep the training record up-to-date
Design GMP production documentation
Design-related GMP documents:
(Master) Batch registration documents with respect to the GDP / GMP guidelines for production, primary and secondary packaging and labeling of materials for clinical trials
Non-conformities (deviations, changes, CAPAs, risk assessments)
Cleaning protocols / reports
Assist (hands-on) during production activities:
Picking and picking verification of materials needed for GMP production
Performance of line clearance and line clearing activities for GMP productions
Preparation of pharmaceutical GMP formulations (such as capsules, liquids, semi-solids, tablets, ...) in a clean room environment using manual and (semi) -automatic techniques
Primary and secondary packaging of GMP materials
Design of clinical labels, printing and quality control
Clinical labeling of GMP materials
Knowledge, experience, profile
Bachelor degree, preferably in the life sciences
Good technical writing skills
Knowledge of GMP / GDP regulations
Fluent in English (written and spoken)
Fluent in Microsoft Office (Word, Excel)
Able to set priorities and manage several in a flexible way.