Specialist, QA Systems

Job description

Job Description

Innovate with intention.

Science is at the heart of what we do.

People are at the heart of why we do it.

Welcome to AbbVie!

We are a global, research-based biopharmaceutical company that combines the focus and passion of leading-edge biotech with the expertise and capability of an established pharmaceutical leader.

Redefining what is possible is our business and our passion.

Our goal is to help patients live healthier lives and we are proud to be a Great Place to Work.

We are recruiting a QA Systems Specialist to join our site in Manorhamilton Road, Sligo. The purpose of this role is to provide an effective QA systems service ensuring that all systems, software & procedures are up to date and maintained within the Quality Department ensuring that all QC systems are kept up to-date, maintained and in line with all data integrity policies and procedures.

This role is key to the continuous improvement of lab automation and related software systems and ensuring all QA systems projects are managed in an efficient and compliant way to meet Department and Plant goals.

Are you intrigued?

Do you want to learn more?

A snapshot of your key responsibilities as a QA Systems Specialist would be:

• 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.
• Evaluate activities, timelines and resources necessary for development of new product set up in SAP/Sample Manager.
  
  Evaluate timeline to build, manage and implement qualified automated calculations for testing of Raw Material, Drug Substance and Finished product.
• Assist cross-functional teams in the execution of strategies for supply of development and clinical supply of new products.
• Co-ordination / direction and active participation in the validation of Sample Manager Calculations and Empower HPLC calculations in compliance with company policies, FDA, European cGMP and GAMP standards.
• Ensure Documentation and Computerized Systems compliance with Data Integrity policies and regulatory requirements.
• Ensure the necessary controls are in place to ensure excellence in regulatory, safety and environmental compliance.
• Maintain/review all documentation relevant to the Laboratories and Qualified persons – advise on specification changes where necessary.
• Approval of Quality documents, e.g. Cleaning Instructions, Specifications where required.

• Liaising with QC systems Contractors/Consultants and Global teams.
• Liaise with Laboratory/Warehouse/Planning and Manufacturing teams regarding sampling and testing schedules/priorities.
• Training of employees on relevant applications as required and Data integrity requirements.
• Supporting the implementation of IT policies relating to quality systems.
• Collaborate with BTS Lab Engineer function on all QC system activities ensuring timely completion of installation / maintenance / upgrades to Quality related IT systems.
• Assist with investigations arising out of non-compliance in incoming materials, QC testing, manufacturing processes, warehousing or product.
  
  Contribute to root cause analysis and identify effective corrective action and preventive action.
• Collaborate closely with Global Local Supply Planning, Site Planning team and Warehouse to ensure materials are configured in SAP and Sample Manager LIMS and align to the approved material specification documents and ensure supply requirements are met.
• 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 Lab Engineer function on all QC system activities.
• Ensuring 6S excellence is maintained across the area of work.
• Project management of QC Systems elements continuous improvement projects.
  
  Manages implementation and execution of Automation of Simple and Complex calculations.
• Project management and technical development of future integrations with QC Systems.
• Provide technical support to all QC system related issues.
  
  Tasks include, daily trouble shooting, optimisation and documentation control.
• Executing and / or supporting projects as assigned by the Quality Services Manager/ Quality Director.
• Create and maintain material specifications and testing requirements in Sample Manager LIMS and SAP.
  
  Responsible for the administration of Empower and management of projects within Empower.
• Responsible for the timely execution and completion configuration of SAP/ Sample Manager & Empower to enable testing of all phases of testing of raw materials, intermediates and finished products.
• Ensure management is kept informed of system failures on a regular basis to ensure corrective/preventive action is taken where required.
• Expected to handle all day-to-day QC system needs for LIMS and SAP.
  
  Individuals are given authority to carry out their duties in a manner which is largely self-managed but with supervision by the Quality Services Manager.

What you will need:

• At least 5 years’ experience in a pharmaceutical environment with relevant IT or QC experience
• BBs in a relevant Science discipline
• Knowledge of LIMS, SAP, and laboratory-based systems an advantage e.g. Empower, Lab-X, Openlab etc.
• Experience working in cross functional teams
• Project Management experience
• Requires total commitment to quality and maintaining a high standard of work at all times.
• Strong communication skills, both verbal and written are required for the execution of this role.
• Strong interpersonal and computer skills are required.

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 

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Required Skill Profession

Computer Occupations