Manufacturing Analyst Project
Manufacturing Analyst Project
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Job Description
We believe the paths we take to achieving our breakthroughs matter. At AbbVie everyone of our 50000* employees is a part of shaping those pathsand defining our way forward.
We are now recruiting experienced Manufacturing Analyst to join our Core 1 Operations team in AbbVie Westport Co Mayo.
In the role you will be performing focused work to provide technical support to the business specifically on the 607 project. You will also support dayday operations activities within the operations function. Other aspects of this role are QMS compiling and review of project documentation (e.g. SOPs methods Master records Batch Records Reports). The candidate will also be coordinating with several departments to holistically develop technical and leadership skills.
If great benefits a defined career path and worklife balance are important in your next career move then read on to find out more:
Key activities:
- Provide technical support to all manufacturing and chemistry related issues. Tasks include daily trouble shooting optimization cost reduction training and coaching of manufacturing personnel
- Support of process front runs / use tests for both NPI and commercial processes.
- When required support commercial operation activities
- Development of process control recipes for NPIs and optimization of existing commercial process recipes
- 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.
- Participate in nonconformance 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 onthefloor technical support to the Production Team Leaders for process/equipment optimization and troubleshooting
- Provide assistance when required at Regulatory Inspections.
- Trending and cordination of customer complaints investigations.
- Work close with department 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 serving our community and embracing diversity and inclusion. It is AbbVies 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.
US & Puerto Rico only to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Fulltime
Employment Type
Full-time
