Quality Officer
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Our client, a leading pharmaceutical company, is seeking a Quality Officer to oversee quality assurance activities for its new biologicals drug substance facility. This role focuses on ensuring compliance within manufacturing operations while driving continuous improvement and adapting to a new production environment.
- Oversee quality assurance activities for Upstream, Downstream, and Media/Buffer operations.
- Review and approve deviations, CAPA, and change controls to maintain compliance standards.
- Execute the review and approval of batch records for production processes.
- Ensure the escalation of quality issues to management in accordance with QMS protocols.
- Participate in Annual Product Reviews and coordinate with stakeholders to align quality with production goals.
- You have a Bachelor's or Master's degree in Biotechnology, Chemistry, Pharmacy, or a related scientific field.
- You bring around 8 years of experience within a GMP environment.
- You possess demonstrated experience in biologicals drug substance operations from a business or quality perspective.
- You're proficient in quality assurance methodologies including CAPA, deviation management, and change control.
- You have strong communication skills and remain resilient in high-pressure operational settings.
- You are fluent in French and English.
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