Sterility Assurance Quality Specialist – Pharmaceutical
Minor Hotels Europe and Americas
full-time
Posted on:
Location Type: Office
Location: Diegem • Belgium
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About the role
- Driving and executing continuous improvement projects and remediation plans related to sterility assurance, including change control management and SOP reviews.
- Managing relationships with aseptic operations teams to ensure compliance with quality standards and regulatory requirements.
- Identifying potential quality and compliance risks and implementing strategies to mitigate these risks through existing quality systems.
- Performing gap analyses, system effectiveness reviews, and other management reviews to ensure ongoing compliance.
- Maintaining cGMP standards in your area of responsibility through proper documentation, audits, training, and method validation.
- Implementing and supporting adequate training programs related to sterility assurance, including shop floor mentoring to enhance operational excellence.
Requirements
- 6+ years of relevant experience in sterility assurance within the pharmaceutical industry and demonstrated expertise in Quality Assurance practices and GxP compliance.
- PhD or Master's degree in Sciences (Microbiology, Engineering, Bio-engineering, Pharmacy) or equivalent experience.
- Strong understanding of pharmaceutical manufacturing processes and regulatory requirements.
- Experience working with cross-functional teams to implement quality improvement initiatives.
- Hands-on approach with a coaching and mentoring style to positively impact individual experiences.
- Fluency in English required; French language skills are advantageous.
Benefits
- Continuous feedback : We take a human-centric approach to foster growth and performance.
- Hybrid working : We encourage flexibility when it comes to when and where work gets done.
- Free access to learning platforms : Free access for all to world-class learning assets and curated programs from Harvard Business Review, Coursera, Pluralsight, Udemy, Microsoft, AWS, Google and many more.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
sterility assurancequality assurance practicesGxP compliancecGMP standardsgap analysessystem effectiveness reviewschange control managementSOP reviewsmethod validationpharmaceutical manufacturing processes
Soft skills
coachingmentoringrelationship managementcommunicationcross-functional collaborationproblem-solvingtraining program implementationoperational excellencerisk mitigationinterpersonal skills