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Senior Validation Specialist for Analytical Science and Technology
2 months ago
We are seeking a highly skilled Senior Validation Specialist for Analytical Science and Technology to join our team at CSL Seqirus. As a key member of our Quality Control team, you will be responsible for ensuring the compliant status of Quality Control method validation lifecycle management and method standardisation/robustness.
Key Responsibilities- Develop and implement Quality Control method validation lifecycle management strategies to ensure compliance with regulatory requirements.
- Collaborate with cross-functional teams to troubleshoot technical challenges with Quality Control test methods and develop solutions to improve method robustness.
- Execute intra-site method transfers and provide SME input into regulatory filings/audits to ensure seamless integration of new methods.
- Develop and maintain current and new test methods, ensuring they are aligned with the latest analytical testing technologies.
- Engage with the latest testing technologies and stay up-to-date with industry best practices to ensure our methods remain compliant and effective.
- Recognized expert in analytical chromatographic methods (HPLC, UPLC) with experience working in pharmaceuticals, particularly biologics (PAGE, CE).
- Proven experience in assay development and validation, with a strong understanding of assay lifecycle from proof of concept to registration.
- Excellent communication and time management skills, with the ability to work effectively in a fast-paced environment.
- Bachelor's degree in a relevant scientific discipline (Chemistry, Biochemistry).
CSL Seqirus is a global leader in the development and manufacture of influenza vaccines. We are committed to making a difference in the lives of people around the world by providing innovative solutions to complex health challenges.
We are an equal opportunities employer and welcome applications from diverse candidates. If you are passionate about making a difference and have the skills and experience we are looking for, please submit your application.
