QA Consultant - Wavre, België - Oxford Global Resources
Beschrijving
QA Consultant - Sterility Assurance (FR/EN):
- Location:
- Contact:
- Job type:
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Do you have an experience in QA and sterile environment ? You are fluent in English and French, eager to work in one of the biggest pharma industry within Belgium? Then, this job might be your next challenge.
For a multinational pharmaceutical company, we are looking for a Quality Assurance role with interest in sterility assurance and validation (Sterility, Risk assessment and environmental monitoring and media simulation).
Responsibilities:
- You mainly perform task related the PQ EM (Performance qualification for clean rooms) (validation) and PQ EM protocols and rapport or other validations.
- You write risk assessments related to the classified environment to limit the risk in the production environment.
- You write gap analysis related to the design of the facilities and contamination control.
- You perform documentary review related SOP (eg : media simulation)
- You review of documents related to validation activities.
- QA oversight and gemba in classified areas.
- Provide support for project coordination and reporting.
Requirements:
- Scientific university degree (Pharmacist, Engineer, Biology or equivalent)
- Fluency and proficiency in French and English language
- Experience in the pharmaceutical / biotech /medical device / food industry or equivalent environment is a plus.
- Aseptic manufacturing process understanding
- Quality performance mindset
- Good analytical and problemsolving skills
- Demonstrated professional and ethical integrity
- Communication in team/management
- Existing right to work in Europe is required
Benefits:
- Balanced salary package based on your skills and experience
- Remote and office work balance
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