This position in CMC and Research Quality Assurance (CRQA) supports the review of raw materials and intermediates for the production of clinical trial material while ensuring compliance with cGMPs, SOPs, and regulatory requirements. Provides support in assuring quality during R&D, deviations and changes involving R&D activities, product technical complaints. Supports the development and maintenance of quality procedures and systems related to area of expertise.
Provide Quality oversight of R&D activities
Reviews executed batch records, certificates of analysis, analytical data, development/validation/ qualification protocols and reports, and product specification files (PSF) for compliance and completeness.
Coordinates batch release activities with R&D and commercial QA/Qualified Person (QP) as required, including the sponsor release for the clinical trial; complies with phase appropriate batch release procedures
Supports the development and implementation of standard operating procedures (SOPs) and supplemental documents governing batch release activities
Ability to identify non-compliances impacting release and report as appropriate for resolution
Provides QA oversight as needed to the manufacture, distribution and testing of products under development in R&D, either in-house or at third party suppliers, including sterile manufacturing and liasing with global sterility assurance as required
Performs minor deviations investigations and product technical compliant investigations
Performs data verification checks as needed for data obtained from area of oversight being provided to regulatory authorities (e.g., approving data included in source documents, regulatory filings or communications with health authorities)
Establishes relationships with R&D QA and other global Quality functions
Advises R&D on applicable requirements, partnering with more senior members in CRQA for complex issues
Acquires and maintains knowledge of Seqirus SOPs and Policies, regulatory requirements and guidance (e.g., Good Laboratory Practice, Good Manufacturing Practice, Quality by Design), to ensure that expert advice and appropriate QA technical support on all quality/compliance-related matters are provided to R&D at the site level for relevant markets
Helps maintain the Quality System in R&D
Identifies and escalates risks to compliance to senior management
Provides QA support and assists R&D in use of existing systems to manage documentation, changes, deviation investigation, CAPA, internal audit processes, commitments to Health Authorities
Supports internal audits and helps prepare for regulatory inspections
Supports inspection finding responses related to applicable area of oversight
Supports the provision of accurate and timely reports on metrics, findings, risks and trends
Bachelor’s degree in a scientific discipline / Life Sciences required (e.g., Biology, Microbiology, Chemistry or Pharmacy)
Masters or PhD preferred.
3+ years in Quality Assurance and/or in a GxP regulated environment within the pharmaceutical industry.
Previous work in a QC, Research, Development, Manufacturing or Quality role required.
Experience working across different market areas and different phases of R&D preferred (Product Development/ GLP Toxicology, Clinical Phase 1, 2 and 3 and commercialization)
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