Quality Assurance Manager
Vor 3 Tagen
We are seeking a highly skilled Quality Assurance Manager to join our team at CSL Behring. As a key member of our Global Quality Engineering department, you will be responsible for ensuring the quality and compliance of our manufacturing processes and facilities.
Key Responsibilities- Quality Oversight: Provide quality oversight and review of design activities and GxP documentation for CAPEX and OPEX commercial portfolio projects at our Bern site.
- Regulatory Compliance: Ensure compliance with GxP, FDA, TGA, EU, and other regulatory agency guidelines and regulations.
- Quality Process Knowledge: Develop and maintain strong quality process knowledge, including SOP review and approval, deviation oversight, and change management.
- Collaboration and Communication: Collaborate effectively with internal and external colleagues and stakeholders to ensure seamless project execution and quality delivery.
- Education: Degree in life sciences and/or engineering; advanced degree preferred.
- Experience: 5+ years of experience in quality assurance and regulatory compliance in the pharmaceutical industry or equivalent combination of education and experience.
- Skills: Strong quality process knowledge, experience in interacting with regulatory authorities, ability to influence at all levels of the organization, and effective communication skills.
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for quality and compliance, we encourage you to apply for this exciting opportunity.
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Quality Assurance Specialist
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