Senior Associate, Global Engineering Quality Specialist
1 month ago
We are seeking a highly skilled Senior Associate, Global Engineering Quality to join our dynamic team at CSL Behring Broadmeadows. In this pivotal role, you will oversee quality for GMP capital projects, ensuring excellence in Technology Transfer, QbD, Commissioning and Qualification, Method Transfer and Validation, Process and Cleaning Validation, CPV, Stability, and more.
As a Quality partner to Process Engineering and Project Delivery teams, you will collaborate with Global Engineering and peers in Quality Engineering, Site QA, and QA-Sterility Assurance to maintain consistent quality standards across all CSL Behring sites.
This is a hybrid, 12-month fixed-term full-time position (secondment for CSL internal candidates) based at our Broadmeadows site.
The RoleReporting to the Manager Global Quality Engineering Lead, you will ensure GMP-compliant project planning and execution. Your responsibilities include:
- Ensuring GMP-compliant execution of project activities within timelines and regulatory requirements (EU, TGA, FDA).
- Supporting quality oversight and approval of:
- Technology transfer documentation, QbD documentation, and risk assessments.
- Commissioning and Qualification documentation packages.
- Validation documentation packages, including process, cleaning, and CPV.
- Method transfer and validation protocols and reports.
- Stability protocols and reports.
- GxP vendor qualification.
- Quality Risk Assessments for relevant capital projects.
- Quality oversight and contributions to changes and deviations as QA project SME.
- Quality Stage Gates.
- Planning, coordinating, and monitoring resource allocation following project plans and CSL priorities.
- Ensuring compliance with internal guidelines and global standards (quality systems, procedures, and work instructions) and regulatory requirements.
- Implementing internal guidelines (SOPs) and global engineering standards according to quality requirements.
We are looking for a candidate with:
- A degree in life sciences or engineering.
- 3+ years of experience in the pharmaceutical industry or equivalent combination of education and experience.
- Experience in quality assurance and regulatory compliance with GxP, FDA, TGA, EU, or other regulatory guidelines in biologics manufacturing and support regulatory submissions and inspections.
- Experience in quality oversight of GMP-compliant manufacturing facilities, commissioning and qualification of production facilities, equipment, cleanrooms, or validation.
Please apply with your cover letter addressing the key selection criteria and your resume by the specified deadline.
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