Bachelor's degree in Engineering, Business, or a relevant scientific discipline (Chemistry, Biology, Microbiology, etc.)
4-8 years of laboratory experience
3-5 years of quality systems experience in a pharmaceutical manufacturing/cGMP regulated environment
Experience with electronic management systems for documents, specifically LIMS preferred
Familiarity with cGMP compliance and regulatory requirements
Responsibilities
Support the development and maintenance of global quality system processes related to LIMS
Administer approved system changes to the LIMS system as necessary
Provide SME guidance locally and globally
Participate in deviation investigations as a LIMS liaison
Compile metrics for Senior Management review
Lead project implementation of electronic system changes globally
Interface with developers to improve system functionality
Benefits
Opportunity to work in a global environment
Engagement in continuous improvement initiatives
Access to training and development programs
Participation in cross-functional team meetings
Involvement in high-impact projects
Full Job Description
Supports the development and maintenance of global quality system processes, procedures and operational activities related to Quality oversight of the Laboratory Information Management System (LIMS), associated with product testing and laboratory data review, which includes, but is not limited to, Document Management, Application of Global Quality Policies & Standards, Change Controls, and Deviation/Corrective and Preventative Action review and administration. Provides LIMS technical support in all cGMP compliance related matters, including assurance that all aspects comply with cGMPs, legal, regulatory requirements, and the Seqirus Quality Manual requirements. Serves as global SME to support the Global LIMS System.
Manage GLIMS processes
Administer approved system changes to the LIMS system, as necessary.
Provide SME guidance locally and globally.
Complies with policies and procedures in order to maintain compliance with legal regulations, health and safety, and regulatory requirements as written.
Participates in all applicable deviation investigations, serving as a LIMS liaison to ensure complete and timely resolution and closure.
Compile pertinent metrics for Senior Management review.
Attends project related meetings as departmental representation, as required.
Performs training on applicable LIMS system roles to support manufacturing, technical development and quality activities.
Actively participate in team meetings.
Support site and function audit preparations with respect to LIMS functionality.
Interface with local and global developers to improve system functionality. This includes manually analyzing meta data and reviewing trends to make recommendations to the business regarding laboratory testing. They are identifying issues and strategizing with the business to implement technical solutions.
Lead project implementation of electronic system changes across the globe.
Actively lead project delivery and support the Change Management team in the preparation and review of stakeholder analysis, role mapping, Change Impact Assessments and job impact assessments where appropriate.
Participate in the testing and validation of the data & test scripts pertaining to the processes of the functional area including:
Integrated systems testing
OQ - Operational qualification
User acceptance testing
Defect management
Interface with other Seqirus and CSL Quality functions to share best practices and identify / leverage opportunities across Quality systems and processes.
Assist in driving GLIMS alignment across the organization.
Participate in system improvement initiatives to optimize the business processes and practices within GLIMS.
Support investigation of deviations and own CAPAs related to systems.
Support evaluations of change controls related to systems.
Qualifications:
Bachelor degree in Engineering, Business or a relevant scientific discipline (Chemistry, Biology, Microbiology, etc.)
4-8 years of laboratory experience
3-5 years' quality systems experience in pharmaceutical manufacturing/cGMP regulated environment
Experience with electronic management systems for documents, specifically LIMs preferred. 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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About CSL Limited
CSL Limited is a global biotechnology company that develops and delivers innovative biotherapies and influenza vaccines to protect public health. They have a focus on rare and serious diseases, and their products are used in more than 70 countries. CSL Limited was founded in 1916 in Australia, and has since grown to become one of the largest biotech companies in the world. They have a strong commitment to research and development, and invest heavily in new technologies and therapies. CSL Limited is listed on the Australian Securities Exchange and the NASDAQ, and has a market capitalization of over $100 billion.
