Manager, Quality Engineering Method Transfer & Stability - Melbourne Australia

Company: Confidential
Your Application: You have not applied yet
Location: Melbourne Australia, Australia
JOB DESCRIPTION

Manager, Quality Engineering Method Transfer & Stability
CSL Behring
Manager, Quality Engineering Method Transfer & Stability

With operations in + nations , employees worldwide, CSL is driven to develop liver a broad range of lifesaving therapies to treat disorders such as hemophilia imary immune deficiencies, ccines to prevent influenzaur therapies are also used in cardiac surgery, organ transplantation rn treatmentr>
CSL is the parent company of CSL Behring qirusSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious ten rare conditionsSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapieseqirus is the second largest influenza vaccine company in the world a transcontinental partner in pc preparedness major contributor to the prevention ntrol of influenza globallyr>
We invite you to take a look at the many career possibilities available around the globe nsider building your promising future at CSL by becoming a member of our team!

ASX Top 5 | Leading Bio-pharmaceutical Company | Life-Saving Therapies
Full Time, Permanent Position, based in Broadmeadows
Work in a diverse rsatile role | Global Employee Share Plan


The Opportunity
Reporting into the Quality Engineering Methods Transfer & Validation Leader, the Methods Transfer & Validation Manager will be provide oversight for projects covering methods transfer & validationou will partner with the process oduct owners of Capex projects at the Broadmeadows manufacturing siten addition, you will support QA oversight of quality sts stems aligned with the Engineering functions in methods transfer, validation MP compliancer>
The Role

Collaborate with internal partners for the execution of all capital projects - EU, AUS hers - to deliver projects on time the required sts gulatory requirements
Delivers a consistent quality approach to facility ocess design capital projects
Provide QA oversight on process within capital project
Support regulatory document submissions e-approval inspections for capital projects
Collaborate with peers in Engineering across manufacturing sites with internal partners for the execution of all methods transfers thod validation to deliver these changes on time the required sts
Carries out Quality decisions regarding methods transfer, method validation mparability studies are aligned with the direction of the Confidential
Participate in risks assessments sures up-to-date information
Ensures quality is represented appropriately for regulatory document submissions gulatory inspections for technical transfer e corresponding activities
Delivers to global engineering sts ocesses consistent with regulatory requirements dustry sts quality systems, policies, procedures rk instructions
Provides input to engineering on the content of an appropriate Documentation owledge Confidential system for the Engineering function
Delivers against global sts for technology transfer validation
Participate in deviations, SQUIPP assessment, ensure compliance of the final deviation reports


Skills perience

University degree in a relevant scientific discipline Pharmacy, Chemistry, Biology, Biochemistry
5+ years' GMP experience in pharmaceutical/biotech/or other regulated industry
Experience within a global matrix Confidential
Knowledge of current Good Manufacturing Practices cGMP principles
Knowledge of appropriate regulatory requirements perience in associated regulatory inspections
Exceptional communication skills, with the ability to build intain strong relationships llaborate effectively with all levels oss functionally within the Confidential


How to apply
Apply now to support CSL Behring during next phase of growthlease include in your application a Cover Letter losing 5pm AEST on 17 br>
As a global Confidential with employees in more than countries, CSL embraces diversity & inclusiont's the foundation of who we areiversity clusion are critical to our Values of patient focus, superior performance, innovation, integrity llaborations a company, we rely on our people's diverse perspectives, ideas, capabilities periences to help us deliver on our promise to our patients, our business r shareholdersr>
Our Culture
At CSL, we are driven by our promise to stakeholders, including our employeesSL is committed to building a workplace where employees can have Promising FUTURES by fulfilling their career aspirations, realising their potential ing part of a purpose-driven company with a Values-based culture
Whether you are becoming an expert in your field, moving across, or upward in the Confidential, we believe our people can enjoy Promising FUTURES where they fulfil their individual career aspirations e inspired by our purpose-driven company lues-based cultureur environment is collaborative, global namic, which fosters innovation tivates the best ightest to succeedbr>
Worker Type:
Employee
Worker Sub Type:
Regular

CSL Behring
Manager, Quality Engineering Method Transfer & Stability

With operations in + nations , employees worldwide, CSL is driven to develop liver a broad range of lifesaving therapies to treat disorders such as hemophilia imary immune deficiencies, ccines to prevent influenzaur therapies are also used in cardiac surgery, organ transplantation rn treatmentr>
CSL is the parent company of CSL Behring qirusSL Behring is

a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious ten rare conditionsSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapieseqirus is the second largest influenza vaccine company in the world a transcontinental partner in pc preparedness major contributor to the prevention ntrol of influenza globallyr>
We invite you to take a look at the many career possibilities available around the globe nsider building your promising future at CSL by becoming a member of our team!

ASX Top 5 | Leading Bio-pharmaceutical Company | Life-Saving Therapies
Full Time, Permanent Position, based in Broadmeadows
Work in a diverse rsatile role | Global Employee Share Plan


The Opportunity
Reporting into the Quality Engineering Methods Transfer & Validation Leader, the Methods Transfer & Validation Manager will be provide oversight for projects covering methods transfer & validationou will partner with the process oduct owners of Capex projects at the Broadmeadows manufacturing siten addition, you will support QA oversight of quality sts stems aligned with the Engineering functions in methods transfer, validation MP compliancer>
The Role

Collaborate with internal partners for the execution of all capital projects - EU, AUS hers - to deliver projects on time the required sts gulatory requirements
Delivers a consistent quality approach to facility ocess design capital projects
Provide QA oversight on process within capital project
Support regulatory document submissions e-approval inspections for capital projects
Collaborate with peers in Engineering across manufacturing sites with internal partners for the execution of all methods transfers thod validation to deliver these changes on time the required sts
Carries out Quality decisions regarding methods transfer, method validation mparability studies are aligned with the direction of the Confidential
Participate in risks assessments sures up-to-date information
Ensures quality is represented appropriately for regulatory document submissions gulatory inspections for technical transfer e corresponding activities
Delivers to global engineering sts ocesses consistent with regulatory requirements dustry sts quality systems, policies, procedures rk instructions
Provides input to engineering on the content of an appropriate Documentation owledge Confidential system for the Engineering function
Delivers against global sts for technology transfer validation
Participate in deviations, SQUIPP assessment, ensure compliance of the final deviation reports


Skills perience

University degree in a relevant scientific discipline Pharmacy, Chemistry, Biology, Biochemistry
5+ years' GMP experience in pharmaceutical/biotech/or other regulated industry
Experience within a global matrix Confidential
Knowledge of current Good Manufacturing Practices cGMP principles
Knowledge of appropriate regulatory requirements perience in associated regulatory inspections
Exceptional communication skills, with the ability to build intain strong relationships llaborate effectively with all levels oss functionally within the Confidential


How to apply
Apply now to support CSL Behring during next phase of growthlease include in your application a Cover Letter losing 5pm AEST on 17 br>
As a global Confidential with employees in more than countries, CSL embraces diversity & inclusiont's the foundation of who we areiversity clusion are critical to our Values of patient focus, superior performance, innovation, integrity llaborations a company, we rely on our people's diverse perspectives, ideas, capabilities periences to help us deliver on our promise to our patients, our business r shareholdersr>
Our Culture
At CSL, we are driven by our promise to stakeholders, including our employeesSL is committed to building a workplace where employees can have Promising FUTURES by fulfilling their career aspirations, realising their potential ing part of a purpose-driven company with a Values-based culture
Whether you are becoming an expert in your field, moving across, or upward in the Confidential, we believe our people can enjoy Promising FUTURES where they fulfil their individual career aspirations e inspired by our purpose-driven company lues-based cultureur environment is collaborative, global namic, which fosters innovation tivates the best ightest to succeedbr>
Worker Type:
Employee
Worker Sub Type:
Regular

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Apply Now
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Confidential

:
37


Location

Arrangements



Industries

Science & Biotechnology


CSL Behring






JOB TYPE
Work Day: Full Time
Employment type: Permanent Job
Salary: Negotiable


JOB REQUIREMENTS
Minimal experience: No experience



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