Quality Specialist (Engineering)

Orion Group Sciences are currently recruiting a Quality Specialist (Engineering) on behalf of our Multinational Pharmaceutical client based in Carlow on an initial 11-month contract (with potential to extend).

The successful candidate will work within a small team that will be mainly responsible for compliance aspects within the Engineering CoE team. This will include but not limited to the completion of investigations, generation and management of change controls and supporting the IFM Compliance and EHS Engineer as required.

Responsibilities:

• Support Engineering activities through documentation generation, equipment and process investigations associated with GMP activities and completion of quality notifications.
• Be a document system expert; this will include document review, approval and document system workflow expedition. Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so. Documents will include SOP's, SWI's, training documents, and change controls.
• Raise CAPA's and conduct investigations. Raise and investigate quality notifications using standard tools and methods, to resolve system issues e.g. FMEA, Fishbone diagrams, 5 why's etc.; implement subsequent corrective action through the change management system.
• Required to comply with Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
• Support and lead Internal Quality audits of Engineering Dept.
• Assist in the management and/or assignment of Engineering training if required
• Work collaboratively to drive a safe and compliant culture in Carlow.
• May be required to perform other duties as assigned.

Knowledge, Skills, Experience, Qualifications:

• Degree qualification or equivalent Min Level 7 (Science, Engineering, Technical)
• Proven track-record in delivering results in a world-class supply organisation.
• A strong career history in pharma (ideally working in a clean utilities and/ or compliance environment) and familiarity with a highly regulated environment.
• Innovative thinker, with excellent decision-making and problem-solving skills.
• Experience of working in a cross functional environment.
• Knowledge of and experience in applying Six Sigma and Lean methodologies.
• Positive, flexible action-oriented attitude
• Experience in Compliance systems such as IPI, SAP etc. a distinct advantage
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
• Report, standards, policy writing skills required
• Lean Six Sigma Methodology experience desired
• Experience working within an Engineering environment in a regulated industry a distinct advantage

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.