Senior Associate, Operational Services
Vor 3 Tagen
Senior Associate, Operational Services We are looking for a Senior Associate, Operational Services in our manufacturing Broadmeadows site.
Reporting to the Manager Operational Services Visual Inspection and Packing, you will manage the implementation of routine changes in response to manufacturing value stream priorities and provide expertise in the facilitation and analysis of minor deviation investigations within manufacturing.
This exciting role is a 12-month fixed-term opportunity.
The Role Change Management
Lead cross-functional task completion of routine changes with short- and long-term time frames on existing and new processes, following standard operating procedures and standardized processes.
Partner with the manufacturing direct operations SMEs to understand the problem statement or opportunity so as to reliably represent the change across the business and enable the direct manufacturing SME to meet the S&O plan.
Set the charter and scope in conjunction with the manufacturing direct SMEs.
Plan and communicate the change, ensuring all stakeholders progress the tasks to completion.
Deviation Management
Investigate deviations of any criticality from within the manufacturing area.
Collaborate with QA and manufacturing to understand the scope and circumstances of the deviation.
Assemble in conjunction with the direct manufacturing team's information to enable QA to assess risk at SQuIPP impact meetings to meet procedural timeframes.
Assemble an investigation team and lead the investigation to closure.
Manage all documentation from investigation initiation to completion.
Review and verify the accuracy and completeness of the investigation.
Communicate investigation and conclusions to key stakeholders and complete any further status updates in collaboration with the QA approver.
Your skills and experience Tertiary Qualification in Sciences or Engineering.
5+ years of experience (R&D, Tech Services, Quality or Manufacturing) in a pharmaceutical, biotechnology, or biological industry.
Demonstrated understanding of cGMP, regulatory requirements and relevant environmental, health, and safety requirements as applicable to secondary manufacturing.
A team player with demonstrated initiative and proven problem-solving, communication skills.
Please include a CV and Cover Letter in your application.
Applications close 5pm AEST on Friday 1st November 2024.
Our Benefits We encourage you to make your well-being a priority.
It's important and so are you.
Learn more about how we care at CSL.
About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases.
Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.
We want CSL to reflect the world around us As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion.
Do work that matters at CSL Behring
Equal Opportunity Employer CSL is an Equal Opportunity Employer.
If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please click here.
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