Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

The Qualified Person (QP) at AbbVie Manorhamilton Road Sligo is responsible for ensuring the compliance and quality of our pharmaceutical products. This role requires expertise in quality assurance practices within an FDA and EMEA approved environment to maintain product safety and integrity. As a QP for the site, you will work closely with our products throughout their manufacturing lifecycle, up until release from the site.

Responsibilities

Ensure compliance with EudraLex Volume 4 EU Guidelines for Good Manufacturing Practice and Annex 16 requirements.
Certify that each batch is manufactured and checked according to relevant laws, GMPs, and product specifications at AbbVie Manorhamilton Road Sligo.
Oversee the disposition of bulk products, determining release or rejection based on manufacturing and testing data.
Assess and resolve day-to-day quality issues, ensuring products meet quality and safety standards.
Support cross-functional teams in process improvement and cost efficiency initiatives.
Provide technical leadership and collaborate with stakeholders to enhance product quality and process optimisation.
Make informed decisions within quality systems, adhering to regulatory standards, and handle quality queries from the operations team.
Promote a culture of excellence in quality and compliance throughout the organisation.
Participate in internal and external audits, ensuring readiness and compliance with quality standards.

Qualifications

Essential: Bachelor's degree in a science discipline and a minimum of 5 years of experience in the pharmaceutical industry.
MSc in Industrial Pharmaceutical Science or equivalent recognised for QP status under Directive 2001/83/EC, Article 49.
Experience as a QP on a license preferrable
Strong cognitive skills to rapidly familiarise oneself with products and processes, along with excellent interpersonal skills.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Recruitment Fraud Alert

We have recently become aware of various recruitment phishing scams targeting job seekers. Please be advised:

AbbVie will never request sensitive personal information (such as bank account details, social security numbers, or payment of any kind) during the recruitment process.
If you suspect you have received a fraudulent offer or communication claiming to be from AbbVie, please do not respond, open any attachments, or click on any hyperlinks.

If you have any questions or concerns regarding the authenticity of a communication alleged to have been made by or on behalf of AbbVie, please contact us immediately.

Protect yourself by verifying job offers and communications. Your safety is important to us.

Where We Work

Role is exclusively performed at a site or office and onsite presence is required. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely*, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.