QC Laboratory Systems Specialist

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.

At AbbVie, our strength lies in our team of experts who conduct  ground-breaking science  on a global scale every day. In choosing your career & life path, choose to be extraordinary!

AbbVie’s operations in Carrigtwohill, Cork is a modern bulk tablet finish facility which manufactures solid and capsule formulations. Innovative new technologies, in combination with the depth of expertise that exists within the local workforce, has allowed those based there to develop and deliver products and processes to support AbbVie’s wider global needs. These range from small scale clinical trial supply to large commercial manufacturing.

 

We are currently recruiting a  QC Laboratory Systems Specialist  who will ensure that all QC systems are kept up to-date, maintained and in line with all data integrity policies and procedures. In this role, you will play a key part in the continuous improvement of lab automation and related software systems (LIMs, SAP, Empower,   Omnic etc.). In addition, you will ensure all lab systems projects are managed in an efficient and compliant way to meet goals.  

Key Responsibilities Include:

 

·         Ensure all Laboratory Computerized Systems compliance with Data Integrity and cGMP policies and regulatory requirements.

·         Application super user on all QC systems.

·         Optimization of QC systems to support lab efficiencies e.g. software calculations, data tracking through software applications etc. Set up and management of all site quality static data Supporting identification and installation of compliant IT systems into QC lab environment.

·         Performance Qualification of hardware and software as required.

·         Understanding and implementing basic data handling requirements within the Quality group.

·         Liaising with QC systems Contractors/Consultants and Global teams.

·         Training of employees on relevant applications as required and Data integrity requirements.

·         Supporting the implementation of IT policies relating to quality systems.

·         Work closely with BTS function on all QC system activities ensuring timely completion of installation / maintenance / upgrades to Quality related IT systems.

·         Building excellent interpersonal relationships with internal and external customers.

·         Acting as key point of contact for internal and external customers to lead projects through to completion.

·         Identifying and implementing improvements in current QC computerized systems.

·         Work closely with BTS function on all QC system activities

·         Ensuring 6S excellence is maintained across the area of work.

·         Executing and / or supporting projects as assigned by the Lab Manager/ Quality Director.

·         Maintaining up-to-date, complete and precise records of all work performed.

·         Ensuring that all safety aspects of the role are adhered to.

·         Expected to handle all day-to-day QC system needs for LIMS, Empower and SAP. 

·         Individual is given authority to carry out their duties in a manner which is largely self-managed but with supervision through the Lab Support Supervisor/Lab Manager.

·         Understanding of Windows operating systems.

·         Understanding of system development life cycle.

·         Proficient in cGMP compliant work practices and systems.

·         Understand basic data handling needs of the Quality Department.

·         Capability to learn new software and systems by reading and understanding technical manuals and instructions. Keep accurate records, follow procedures, and comply with company policies

·         Proficient in the use of problem-solving skills and data trending analysis.

·         Ability to meet urgent timelines.

 Education & Experience:

• Relevant 3rd level degree


• At least 3 years’ experience in a pharmaceutical environment with relevant IT or QC experience


• Knowledge of LIMS, SAP, and laboratory based systems an advantage e.g. Empower,etc.


• Working in cross functional team


• Training new starts


• Project Management

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.