Deviation Coordinator

Aufgaben Unter der Marke BioLife betreibt Takeda in Österreich aktuell 14 hochmoderne Plasmaspendezentren. BioLife ist ein Branchenführer in der Sammlung von Plasma in höchster Qualität. Blutplasma kann nicht künstlich hergestellt werden und ist Ausgangsmaterial für unzählige lebensrettende Therapien. Unsere MitarbeiterInnen sorgen mit ihrer langjährigen Erfahrung und Expertise für eine sichere und angenehme Plasmaspende, was rund 30.000 SpenderInnen bestätigen können, die sich jährlich für die BioLife Plasmazentren entscheiden. Unser täglicher Motivator ist das Wissen, dass Plasma nicht künstlich hergestellt werden kann und wir einen wichtigen Beitrag leisten, um den ständig steigenden Bedarf zur Herstellung lebensrettender Therapien zu decken.

In this multifaceted role, you will be responsible for mainly remote support and coordination of deviations and CAPAs for the Austrian BioLife plasma centers. You will act as the central contact for deviation owners and approvers, providing expert support and ensuring compliance with Quality standards. As a skilled project coordinator and problem solver, you will guarantee that all aspects of Safety, Compliance, Quality and Production targets are being considered to optimize Deviation and CAPA performance and metrics within BioLife.

Your Opportunity:

• Drive standardized processes and continuous improvement of supporting tools for processing of deviations and CAPAs
• Closely cooperate with the Austrian Plasma Center teams and Quality Assurance BioLife Europe
• Regular alignment with the local Deviation Coordinators in the Czech Republic and Hungary to ensure a standardized approach and continuous improvement across the network
• Provide support in the documentation and processing of deviations according to current Quality standards
• Lead investigations and CAPAs, with focus on events of high importance and/or complexity
• Provide training and coaching for deviation and CAPA owners and approvers as well as Investigation Leads within the Austrian BioLife plasma centers
• Identify trends and improvement opportunities

Your Skills and Qualifications:

• Completed education in the technical, biochemical, health/medical field, or equivalent work experience
• Experience with working in a pharmaceutical area or another GMP regulated industry
• Ideally 1-2 years experience with deviation management in a GMP environment
• Fluency in English and very good knowledge of German, other languages are beneficial (e.g. Hungarian, Czech)
• Good knowledge of GMP requirements
• Excellent communication and interpersonal skills
• Good project coordination skills and ability to manage multiple topics simultaneously
• Strong analytical and problem-solving skills
• Flexibile and open-minded teamplayer enjoying collaboration with multiple departments and stakeholders
• Willingness to travel 5% (mainly in Austria), the rest of the working time can be managed in a mixture of homeoffice and from the Takeda headquarter in Vienna and/or one of our plasma centers in Austria

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Takeda encourages and supports its employees by trainings, job rotations and mentoring. A balanced work - life ratio (recognition for work and family, company kindergarten) and numerous benefits (fitness center, cafeteria, etc.) complete our profile as a top employer. For more insights into Takeda click here .

We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Gender, age, skin color, background or sexual orientation play no role in this as we actively promote diversity. We equally address people with disabilities. In the course of a recruitment process which is as free of barriers as possible, we encourage you to mention all relevant information in this context in your application.

Motivated employees must be remunerated accordingly. The minimum salary for this important and responsible position is € 3.307,50 gross/month (full time, collective wage agreement for the chemical industry) plus attractive annual bonus. The actual remuneration package will be guided by your professional experience and your qualifications, so increased payment is possible.

We are looking forward to your application at BioLife

Profil
Wir bieten Unter der Marke BioLife betreibt Takeda in Österreich aktuell 14 hochmoderne Plasmaspendezentren. BioLife ist ein Branchenführer in der Sammlung von Plasma in höchster Qualität. Blutplasma kann nicht künstlich hergestellt werden und ist Ausgangsmaterial für unzählige lebensrettende Therapien. Unsere MitarbeiterInnen sorgen mit ihrer langjährigen Erfahrung und Expertise für eine sichere und angenehme Plasmaspende, was rund 30.000 SpenderInnen bestätigen können, die sich jährlich für die BioLife Plasmazentren entscheiden. Unser täglicher Motivator ist das Wissen, dass Plasma nicht künstlich hergestellt werden kann und wir einen wichtigen Beitrag leisten, um den ständig steigenden Bedarf zur Herstellung lebensrettender Therapien zu decken.

In this multifaceted role, you will be responsible for mainly remote support and coordination of deviations and CAPAs for the Austrian BioLife plasma centers. You will act as the central contact for deviation owners and approvers, providing expert support and ensuring compliance with Quality standards. As a skilled project coordinator and problem solver, you will guarantee that all aspects of Safety, Compliance, Quality and Production targets are being considered to optimize Deviation and CAPA performance and metrics within BioLife.

Your Opportunity:

• Drive standardized processes and continuous improvement of supporting tools for processing of deviations and CAPAs
• Closely cooperate with the Austrian Plasma Center teams and Quality Assurance BioLife Europe
• Regular alignment with the local Deviation Coordinators in the Czech Republic and Hungary to ensure a standardized approach and continuous improvement across the network
• Provide support in the documentation and processing of deviations according to current Quality standards
• Lead investigations and CAPAs, with focus on events of high importance and/or complexity
• Provide training and coaching for deviation and CAPA owners and approvers as well as Investigation Leads within the Austrian BioLife plasma centers
• Identify trends and improvement opportunities

Your Skills and Qualifications:

• Completed education in the technical, biochemical, health/medical field, or equivalent work experience
• Experience with working in a pharmaceutical area or another GMP regulated industry
• Ideally 1-2 years experience with deviation management in a GMP environment
• Fluency in English and very good knowledge of German, other languages are beneficial (e.g. Hungarian, Czech)
• Good knowledge of GMP requirements
• Excellent communication and interpersonal skills
• Good project coordination skills and ability to manage multiple topics simultaneously
• Strong analytical and problem-solving skills
• Flexibile and open-minded teamplayer enjoying collaboration with multiple departments and stakeholders
• Willingness to travel 5% (mainly in Austria), the rest of the working time can be managed in a mixture of homeoffice and from the Takeda headquarter in Vienna and/or one of our plasma centers in Austria

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Takeda encourages and supports its employees by trainings, job rotations and mentoring. A balanced work - life ratio (recognition for work and family, company kindergarten) and numerous benefits (fitness center, cafeteria, etc.) complete our profile as a top employer. For more insights into Takeda click here .

We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Gender, age, skin color, background or sexual orientation play no role in this as we actively promote diversity. We equally address people with disabilities. In the course of a recruitment process which is as free of barriers as possible, we encourage you to mention all relevant information in this context in your application.

Motivated employees must be remunerated accordingly. The minimum salary for this important and responsible position is € 3.307,50 gross/month (full time, collective wage agreement for the chemical industry) plus attractive annual bonus. The actual remuneration package will be guided by your professional experience and your qualifications, so increased payment is possible.

We are looking forward to your application at BioLife

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