Sterility Assurance Specialist
2 weeks ago
Responsibilities:
- Under general supervision, provides support on Quality systems to ensure compliance with company standards and GMP regulatory guidelines
- Develops, maintains and improves GMP-related quality control systems including standard operating procedures (SOPs)
- Supports quality systems related to Validation, LIMS, Calibration, Document Management, Deviation Management, CAPA, Change Control, and Enterprise Learning Management
- Collects, collates, evaluates, and reports on Quality performance data of assigned business areas
- Conducts internal audits and assists with 3rd party supplier audits; implements continuous improvement projects
- Collaborates to resolve technical issues, provide quality training and communicate best practices
Qualifications:
- Bachelor degree in Engineering, Business or a relevant scientific discipline (Chemistry, Biology, Microbiology, etc.)
- 3-5 years' quality systems experience in pharmaceutical manufacturing/cGMP regulated environment
- Knowledge of current Good Manufacturing Practices (cGMP)
- Knowledge of FDA and EMA requirements
Knowledge / experience of sterile environments
Our Benefits
CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the
benefits
you can participate in when you join CSL Seqirus.
About CSL Seqirus
CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about CSL
Seqirus
We want Seqirus to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about
Diversity & Inclusion
at CSL Seqirus.
Do work that matters at CSL Seqirus
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