Translate the input from the Project Managers to tasks on the work-floor
Review Technical Quality Agreement and drafts the internal instructions
Draft and train Master Batch Record Documentation and Batch Record Documentation templates and ensure their strict use
Coordinate the purchase and the availability of starting materials prior to start of GMP Production
Plan and follow up the GMP Production activities, areas and equipment
Assist the Associate scientists in documenting non-conformances to guarantee the quality and compliancy
Communicate with QA for follow up and strategy to be followed for non-conformances
Responsible for resolving and discussing quality related issues with QA/QP
Write the GMP manufacturing reports
Assist in meeting with Contract Givers
You report to the Director Formulation and Production
Profiel van de kandidaat
You have a master or a PhD with scientific orientation (Pharmaceutical Sciences, Bioscience-Engineering, Science or Chemical Engineering, …) or equivalent by experience
You have hands-on experience with the preparation of different galenic forms (oral and/or parenteral dosage forms) and knowledge of the process to produce different galenic forms
Experience in a GMP environment is mandatory
Experience in aseptic fill and finish activities is preferred
Experience in formulation development is an asset
You have strong coordination and organization skills
You are able to coach and motivate the operators/scientists executing the work
You have strong reporting skills (oral, written, presentations)
You are a team player
You show flexibility and you are open-minded and change oriented (always looking for ways to improve)
Werkomstandigheden
A true learning environment where you will have the ability to grow your skills
A rapidly International developing and growing company with an interesting services, product and customer portfolio
A dynamic working environment with nice colleagues
Open straightforward but also caring culture
We are true to our values
An attractive remuneration package
Flexible working hours
32 days holiday a year
Contact
If you are interested in this position and would like to know more about it, please contact: