Manufacturing Analyst

Westport, Co Mayo
Contract
Full-time

17 days ago

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 DescriptionAbbVie helps people around the world live better days and better lives each year. And that takes all of us.We are now recruiting for a Manufacturing Analyst to join our newly formed Central Cervices Team in AbbVie Westport, Co Mayo on an initial 12 months fixed term contract.Established in 1977, AbbVie Westport is a Centre of Excellence for Aseptic for Commercial manufacturing of Biologics & Eyecare (pharmaceutical) products. In this role you will be actively involved and manage the batch related CAPA's as they arise in the business unit taking them from the initial review state through RCA, approval, batch disposition and delivery of corrective and preventive actions, liaising closely with the relevant Departments and QA Lead to ensure thorough investigations are complete in a timely manner.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:

Use and maintenance of data within key systems such as SAP, S4HANA, Global Trackwise, POMs, One Track, One Vault and Compliance wire.
Document retrieval from local files and archives, as required for submissions, customer requests and others.
Tracking and Analysis of EM trends within the Eyecare Business Unit
Management of training curriculum for all using eLMS
Participate in and lead non-conformance and exception investigations as necessary.
Complete manufacturing investigations for LIRs.
Open and lead change control records using One Track.
Work with QA Teams to align and promote awareness on data integrity and good documentation practices.
Provide assistance when required at Regulatory Inspections.
Trending and co-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.

QualificationsEducation 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 and aseptic practices, data integrity requirements and GDP is required for this role.
Strong organizational skills and attention to detail are essential for this role.
Good interpersonal relations/communications skills

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:

AbbVie

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