For one of our clients located in the Walloon Brabant, we are looking for an experienced QA Consultant in Sterility Assurance.
- Do you have a Master Degree in Sciences or Engineering?
- Do you have at least 5 years of experience in a QA position within a pharmaceutical/biotech industry (GMP environment)?
- Are you fluent in French and in English?
Then, you might be the candidate we are looking for!
As a QA Consultant in Sterility Assurance, your role is to assure and maintain the organization of the activities linked to the assurance sterility oversight of the manufacturing activities. You define the action plan in collaboration with the production team to assure that the quality systems are in place for assurance sterility project. You continuously endure that the quality of assurance sterility practices and requirements are done in a timely manner.
- You ensure a regular shopfloor in production areas; verify the respect of GMP and procedures in place and identify gaps, define action plans in collaboration with the production team
- You participate in the implementation of the quality systems (Assurance sterility aspect) in the new production area to assure compliance of consistency campaign and the commercial production
- You give support to redaction and approval of documentation: Gap Analysis, Risk Assessments
- You identify, develop and implement improvements to the quality oversight processes
- You develop and implement de EM qualification
- You have a Master degree in Sciences/Engineering (Pharmacist, Master in Sciences, Bio-Engineer pharmaceutical, ...)
- You have at least 5 years of experience in a Pharmaceutical/Biotech industry (GMP environment)
- You have knowledge of vaccines and/or immunology process and products (manufacturing)
- You are fluent in French and you have a good level in English (oral and written)
- You have Good interpersonal relationship skills
- You are a good player in order to succeed in each Assurance Sterility project and routine activities
+32 10 68 53 30