Manufacturing Analyst
Manufacturing Analyst
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Job Description
AbbVie 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 CAPAs 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.
Qualifications :
Education and preferred experience:
- Bachelors 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 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 & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Employment Type
Full-time
