Quality Global LIMS Administrator
CSL
Summary
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, including 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 and serves as global SME to support the Global LIMS System.
Job description
Manage GLIMS processes
- Administer approved system changes to the LIMS system, as necessary.
- Provide SME guidance locally and globally.
- Complies with policies and procedures to maintain compliance with legal regulations, health and safety, and regulatory requirements.
- 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, including manually analyzing meta data and reviewing trends to make recommendations regarding laboratory testing.
- 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, and 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.
Requirements
- 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
Company overview
CSL Limited is an Australian multinational specialty biotechnology company that researches, develops, manufactures, and markets products to treat and prevent serious human medical conditions. Founded in 1916 as Commonwealth Serum Laboratories, CSL has grown to become the world's fifth largest biotechnology company with operations in over 35 countries. The company specializes in blood plasma derivatives, vaccines, antivenoms, and cell culture reagents used in medical and genetic research applications. CSL operates through several key divisions including CSL Behring (focusing on rare and serious diseases), CSL Seqirus (one of the world's largest influenza vaccine providers), CSL Plasma, and CSL Vifor. With over 32,000 employees globally, CSL maintains a strong R&D pipeline and has invested over US$3.3 billion in research and development over the past five years. The company is publicly traded on the Australian Securities Exchange and has its global headquarters in Parkville, Melbourne, Australia.