Job Information
AbbVie QA Document Controller 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
There are many ways to be a difference maker. Find yours.
We are now recruiting for a QA Document Controller to join our Quality Systems team in AbbVie Westport, Co Mayo on a Fixed Term Contract.
As our new QA Document controller you will be accountable for your individual areas of responsibility within AbbVie Pharmaceuticals – supporting the business within the manufacturing and packaging environments. In this role you will show competence and skills to print & issue batch records consistently to GMP standards in a timely manner, ensuring customer order timelines are met. Working closely with their manager, you will work to meet company goals and objectives, customer requirements and the regulatory obligations as lay down by the FDA, EU and regional Ministries of Health.
Flexibility around shifts is required, as this is a shift based role, working the second (evening) shift.
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 you will perform in the role:
Printing & Issuance of Batch File Documentation using a combination of SAP and One Vault and distributing to the Business Unit.
Review of Business Unit printed and bound Logbooks, with issuance of number once reviewed and acceptable.
Review of the final reviewed Business Unit logbooks, and update of logbook register to record closure.
Maintenance and update of Batch Issuance Dept. Procedures.
Maintain strong relationships with management and colleagues in the business units, support functions and the quality department.
Monitor email repository to ensure that all batch file paperwork is printed in line with the schedule.
Ensure batch documentation is available for the Business Unit prior to batch manufacture.
Issue and close logbooks for manufacturing / packaging areas in line with GMP standards.
Ensure logbooks compiled by the Business Unit are in line with the current effective procedures.
Correct access for the use of Quality Systems (SAP / One Vault) in order to print / update and review documentation as required.
Articulate the necessary quality requirements in a clear, concise and persuasive manner.
Attend all routine meetings as required and support site initiatives by fostering an environment of continuous improvement.
Qualifications
So, what do you need to do this role?
Qualifications:
Leaving certificate
Proficient in the use of Microsoft programs such as Word and Excel.
A good knowledge and understanding of production processes.
Excellent communication skills, oral and written.
Experience working with SAP and One Vault is a distinct advantage
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.