This is an excellent opportunity to join a high profile global manufacturer based out of Cork. This expanding team have strong working relations with both internal and external business stakeholders.
This business pride themselves on innovation, efficiency, and maintaining high standards of quality across all operations. The team are currently seeking a highly skilled Computer Systems Specialist with a strong focus on Quality Assurance (QA) and Manufacturing Execution Systems (MES) support. The ideal candidate will be responsible for ensuring the quality and reliability of the computer systems, as well as supporting and maintaining MES applications to enhance the manufacturing processes.
Main Purpose and Objectives of Position:
- Provide Quality leadership, direction, and governance for MES and MES related systems.
- Investigate and troubleshoot issues relating to MES and MES related systems.
- Approve appropriate quality-related documents.
- Promote and encourage Quality culture and promptly report any compliance concerns.
- Participate in quality meetings keeping the group updated on initiatives within the QA owned GMP MES systems.
- Contribution to the Quality Plan (GMP Plan) for specific Quality System/ Programme Initiatives.
- Assure consistent implementation of standards across the Quality System.
- Assure that the Quality system(s)/Program remains in a validated state and aligned within regulatory commitments.
- Interpretation and application of emerging Regulatory & GMP guidelines to the specific Quality System(s)/Program.
- Review and approval of change controls, deviations, failure investigations, if applicable.
- Review and approval of key GMP documents such as GMP standard operating procedures and CSV deliverables as appropriate to area of responsibility.
- Review and approval of GMP documents associated with qualification and validation including IQ/OQ/PQ & validation documents for facilities, equipment, computer systems, GMP utilities and system periodic review reports as appropriate to area of responsibility.
Key Attributes
- Bachelor's degree in a related field.
- Minimum of 3-5 years of experience in Quality Assurance and ideally with MES support.
- Proficiency in QA methodologies, tools, and best practices.
- Excellent attention to detail and strong organisational skills.
- Experience working in cross functional teams and proven ability in decision making.
- Demonstrates ability in critical thinking, data analysis, problem solving and experience in root cause analysis.
- Strong organisational skills, including ability to follow assignments through to completion.
- Strong understanding of Data Integrity and its applications
- Demonstrates flexibility and adaptability to meet business needs.
This is initially a 12 month contract role with possibility of extension.
If you would like to find out more about this role please click the 'Apply Now' button below or reach out to Kellie on 021 2300 300.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
