Validation Manager
Validation Manager
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Job Description
We are now looking for a Validation Manager to join our team in Ballytivnan in Sligo. As a Validation Manager at AbbVie you will develop and maintain the AbbVie Biologics Ballytivnan (ABB) validation program ensuring compliance with AbbVie and external regulatory quality and compliance requirements. Your role will actively involve participating in the validation program and general quality assurance activities.
Key Responsibilities:
- Lead a team of validation professionals to fully support all validation activities for the biologics products on site.
- Coordinate and direct the validation and qualification of ABB equipment utilities processes and software ensuring compliance with AbbVie policies FDA European cGMP and GAMP standards.
- Generate maintain and execute Project Validation Plans and schedules as well as validation protocols and final reports to cGMP standards.
- Provide QA support for validation investigations implementing corrective actions as required.
- Create review and approve validation and qualification documents managing validation exception events and change control processes.
- Document all validation activities in compliance with cGMP requirements.
- Perform crosstraining within the team and train new team members.
- Participate in continuous improvement programs to implement enhancements in manufacturing quality safety and training systems.
- Coordinate activities to maximize team effectiveness and communicate with peers and management regarding area activities including elevation of significant events or concerns.
- Engage in crossfunctional teams and cost improvement projects demonstrating influence and leadership to guide team efforts.
Qualifications :
- Qualification and/or degree in engineering or a scientific discipline.
- Over 3 years of validation/quality experience in a sterile/aseptic environment particularly in commissioning and qualification areas.
- 2 years of people leadership experience
- Minimum of 3 years of experience in a cGMP regulated environment.
- Extensive knowledge of cGMP and regulatory requirements in the pharmaceutical industry.
- Strong written and oral communication presentation and troubleshooting skills.
- Effective interpersonal organizational and leadership skills demonstrating the ability to work independently and collaboratively in a team.
Why AbbVie
Join AbbVie and contribute to a team dedicated to pioneering scientific research and development. We offer opportunities for professional growth and a collaborative work environment focused on achieving excellence.
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.
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No
Employment Type :
Fulltime
Employment Type
Full-time
