We are now recruiting an experienced Manufacturing Analyst and Documentation Coordinator to join our Core 1 Operations team in AbbVie Westport, Co Mayo on a fixed term 12 month contract.

In the role, you will have the opportunity to coordinate batch record flow, corrections, manufacturing status tracking spreadsheets, report preparation, Complaints tracking. The successful candidate will perform reviews of manufacturing and other paperwork to ensure compliance to Abbvie and regulatory standards. The manufacturing analyst will be required to communicate up to date status reviews and work with Manufacturing Technicians, Technical Writers and Technical Shift leads to coordinate and ensure the completion of manufacturing batch paperwork.   

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.
• Management of purchasing requisitions.
• Provide assistance when required at Regulatory Inspections.
• Trending and c-ordination of customer complaints investigations.
• Work close with Depts on corrective actions arising from Environmental excursions.  
• Comply with Abbvie policies and procedures and regulatory agency regulations.