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De missie van AbbVie is het ontdekken en leveren van innovatieve geneesmiddelen die vandaag een oplossing bieden voor ernstige gezondheidsproblemen en de medische uitdagingen van morgen aanpakken. We streven ernaar om een grote impact te hebben op het leven van mensen in verschillende belangrijke therapeutische domeinen: immunologie, oncologie, neurowetenschappen, oogzorg, virologie, vrouwengezondheid en gastro-enterologie, naast producten en diensten uit de portefeuille van Allergan Aesthetics. Bezoek www.abbvie.com voor meer informatie over AbbVie. Volg @abbvie op Twitter, Facebook, Instagram, YouTube en LinkedIn.

Validation Manager

Sligo, Ierland Job ID 2121029 Categorie Quality Assurance Afdeling 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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