QA BMR Reviewer

Job title:

QA BMR Reviewer

Company:

AbbVie

Job description

Company DescriptionAbbVie’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 . Follow @abbvie on , , , , and .Job DescriptionWelcome to AbbVie!We are a global, oral solid dose company that combines the focus and passion of leading-edge research with the expertise and capability of an established pharmaceutical leader. Redefining what is possible is our business and our passion. Our goal is to help patients live healthier lives and we are proud to be a Great Place to Work.We are now recruiting a QA BMR Reviewer to join our diverse QA team in Clonshaugh, Dublin.Are you intrigued? Do you want to learn more?A snapshot of your key responsibilities as a QA BMR Review Technician would be:

• Reviews BMRs for completion and accuracy.
• Reviews CPPs of BMRs to ensure there were no deviations from the filed process.
• Raise and support the completion of CAPAs, Non-conformances and Change Controls.
• Review, collate and submit the necessary documentation to support QP release of finished product in accordance with Annex 16.
• Responsible for the management of the retain system for samples and documents.
• Provide assistance in departmental and regulatory audits.
• Has the ability to train a colleague in a particular GMP procedure or related activity.

Qualifications

• A third level qualification in a scientific discipline, preferably a B.Sc./M.Sc.
• Pharmaceutical experience with good working knowledge of cGMP.
• Strong knowledge of FDA/EMEA regulatory requirements.
• Excellent organizational, communication and interpersonal skills.
• Ability to set and maintain the highest standards.

Additional InformationAbbVie 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, visitUS & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Expected salary

Location

Dublin

Job date

Wed, 23 Apr 2025 00:31:47 GMT

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