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關於 AbbVie

AbbVie 的使命是發現並提供創新藥物,解決當今嚴重的健康問題,同時面對未來的醫學挑戰。除了 Allergan Aesthetics 產品組合中的產品及服務外,我們還致力在幾個關鍵治療領域為人們的生活帶來顯著影響:免疫學、腫瘤學、神經科學、眼科、病毒學、女性健康和胃腸病學。如需瞭解更多有關 AbbVie 的資訊,請造訪我們的網站。在 Twitter、Facebook、Instagram、YouTube 和 LinkedIn 追蹤 @abbvie

Validation Manager

Sligo, 爱尔兰 職位 ID 2121029 類別 Quality Assurance 部門 AbbVie

Ready to lead a high performing team? We offer that
Want to invest in your career development? We offer that too

Welcome to AbbVie!

At AbbVie, we offer you the resources and a global reach to empower your innovative mindset.   From day one, we’ve known it takes teamwork and collaboration to develop the scientific breakthroughs, innovative pipelines, and therapies that change millions of patients’ lives around the world. In short, we know it takes “you” to make those ground-breaking advancements happen. We take pride in serving and supporting our communities and protecting the environment, making a lasting impact that's felt within healthcare and beyond.

We are currently recruiting a Validation Manager (Leader) to be part of our extended leadership team in our Ballytivnan site in Sligo. Reporting directly to the Quality Director, you will lead a high performing team that is responsible for the development and maintenance of the biologics validation program and ensure AbbVie and external regulatory, quality, and compliance requirements are met.

Does this role entice you? Then read on for some of the day-to-day responsibilities:

•    Develop, coach and mentor your team to perform to their highest capabilities
•    Coordination / direction and active participation in the validation and qualification of equipment, utilities, processes and software in compliance with AbbVie policies, FDA, European cGMP and GAMP standards.
•    Generation/maintenance/execution of Project Validation Plans and schedules
•    Generation of validation protocols and final reports to cGMP standards.
•    QA support for validation investigations and implementation of corrective actions.
•    Creation/Review/Approval of various validation and qualification documents
•    Management of validation, exception event, and change control processes.
•    Documenting all activities in line with cGMP requirements.
•    Performing cross training within the team and training of new team members.
•    Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems.
•    Coordinating activities to maximize the effectiveness of all of the team members. 
•    Communicating with peers and management regarding activities in the area, including elevation of events or concerns.

Qualifications:

So, what education & experience do you need for this role?

You will have 
•    A relevant degree in engineering or scientific discipline with 3 years plus validation/Quality experience in sterile/aseptic environment especially in the commissioning and qualification area  
•    3 years plus of knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry
•    Demonstrated leadership capabilities to build and coach a diverse team
•    Ability to partner and provide technical expertise to wider leadership team and cross functional teams

So, does this all sound like the right role for you? Then come join Abbvie! 

AbbVie is an Equal Employment Opportunity Employer; we value bringing together individuals from diverse backgrounds to develop innovative solutions for patients and being part of an inclusive work environment. 

Travel: No
Job Type: Experienced
Schedule: Full-time
ABBVIE

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