Quality Assurance Specialist
Vor 3 Tagen
We are seeking a highly skilled Quality Assurance Specialist to join our team at CSL Behring. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our products.
Key Responsibilities- Quality Assurance Systems Management
You will be responsible for maintaining and ensuring the effectiveness of our Quality Assurance Systems, including affiliate quality management systems, to ensure compliance with company standards and regulatory guidelines.
Learning Management System AdministrationYou will manage our affiliate Learning Management System, ensuring that all necessary training and development programs are in place to support the quality and compliance of our products.
Collaboration with Site QAYou will work closely with our Site QA team to ensure timely release of products to the market, while maintaining the highest standards of quality and compliance.
Investigations and ReportingYou will support investigations and reporting of product technical complaints, ensuring that remedial actions are implemented to prevent future occurrences.
Customer Inquiries and SupportYou will collaborate across departments to resolve customer inquiries and provide support on quality-related matters.
Procedure Maintenance and TrainingYou will maintain all procedures (SOPs, work instructions) within your responsibility and provide quality-related training to the affiliate team.
Inspection ReadinessYou will ensure that the affiliate is inspection-ready at all times, meeting the highest standards of quality and compliance.
Quality Agreements ManagementYou will work with Global Supplier Quality to manage Quality Agreements, ensuring that all necessary agreements are in place to support the quality and compliance of our products.
Requirements- Education
You must have a Bachelor's degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry).
ExperienceYou must have at least 5 years of GMP experience in pharmaceutical/biotech/or other regulated industry.
Global Matrix Organization ExperienceYou must have experience working within a global matrix organization.
Knowledge and SkillsYou must have knowledge of current Good Manufacturing Practices (cGMP) principles and regulatory requirements.
Language RequirementsYou must be proficient in German, English, and French (beneficial).
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