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 cross-training 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 cross-functional 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.