QA Systems Specialist

Team Horizon is seeking a QA Systems Specialist for our client based in Cork. The QA systems Specialist 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.  
 
 
Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.


• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.


• Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.

 
What you will be doing:

• 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.


• Excellent attention to detail, proven track record of RFT.


• Good organizational and interpersonal skills will be required.


• Ability to present on area of responsibility during regulatory inspections and corporate audits if required.


• Data Integrity program owner for QC lab.

 
What you need to apply:

• 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