Job Information
AbbVie Batch Review Co-Ordinator in Westport, Ireland
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 Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
If you want to be a difference maker, our people are waiting. See the difference you can make at AbbVie.
We are now recruiting an experienced Batch Record and Documentation Coordinator to join our Core 1 Operations team in AbbVie Westport, Co Mayo.
In the role, you will have the opportunity to coordinate batch record flow, corrections, status tracking spreadsheets and prepare reports. The successful candidate will perform reviews of manufacturing and other paperwork to ensure compliance to AbbVie and regulatory standards. The Batch Record Coordinator will be required to communicate up to date status reviews and work with Manufacturing Technicians, Technical Writers and Technical Shift leads to drive completion of paperwork.
If great benefits, a defined career path, and work-life balance are important in your next career move, then read on to find out more:
Key activities:
Compile and perform manufacturing audit review of batch paperwork from manufacturing areas.
Ensure all batch records components are present and that all corrections identified during initial review and by Product Release Team are addressed in a timely and compliant manner.
Use and maintenance of data within key systems such as SAP, S4HANA.
Document retrieval from local files and archives, as required for submissions, customer requests and others.
Participate in non-conformance and exception investigations as necessary.
Work with QA Teams to align and promote awareness on data integrity and good documentation practices.
Facilitate and coordinate with project teams to enhance, improve and streamline batch records.
Provide assistance when required at Regulatory Inspections.
Comply with Abbvie policies and procedures and regulatory agency regulations.
Qualifications
Education and preferred experience:
Bachelor’s degree in science, or a related field is preferred and/or a minimum of 2 years’ experience in a similar role.
Detailed knowledge of cGMP, data integrity requirements and GDP is required for this role
Strong organizational skills and attention to detail are essential
Good interpersonal relations/communications skills
Additional Information
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s 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.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s 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.