Responsibilities
- Responsible for sterility assurance business site projects presenting high complexity, including implementation and qualification of new filling lines and engineering changes to the facility
- Develops the sterility assurance project strategy, scope and objectives, involving all relevant stakeholders, and ensuring technical feasibility
- Predict and manage resources needed to reach project objectives, monitor project progress, timeline, and budget tracking
- Leads/coordinates complex project related deviations, reporting of product technical complaints and implementation of remedial actions
- Supports preparation, successful conduct and follow-up of regulatory inspections, self-inspections and customer audits as required
- Responsible for the generation and review of the documentation
Qualifications
- Bachelor's degree in Microbiology, Biology, Chemistry, Biochemistry, or life sciences or equivalent relevant field; advanced degree preferred
- 7+ years' experience in pharmaceutical manufacturing industry and GMP experience in pharmaceutical, biotech, or other regulated industry
- Experience interacting with regulatory authorities including submissions and inspections; knowledge of auditing practices and procedure
- Experience within a global matrix organization
- Demonstrated success in project management and business/QA systems
- Knowledge of appropriate regulatory requirements including GMP/GQP
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
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Snr Manager Sterility Assurance employer: CSL
CSL Seqirus is an excellent employer that fosters a collaborative and inclusive work culture, making it an ideal place for a Global Financial Analyst. With a strong focus on employee growth and development, the company offers numerous opportunities for professional advancement while providing a hybrid working model that promotes work-life balance. Located in Speke, Liverpool, employees benefit from a vibrant community and the chance to engage with diverse teams across the globe, enhancing both personal and professional experiences.
