Associate Quality Specialist

Orion Group Life Sciences are currently recruiting an Associate Quality Specialist on behalf of our Multinational Biopharmaceutical Client based in Carlow on an initial 11-Month contract with potential to extend. 4 Cycle shift.

The successful candidate will:

• Work a 4 shift pattern role
• Technical knowledge of sterile manufacturing processes
• Perform timely reviews of batch documentation / investigations / reports highlighting and assist in the resolution of concerns commensurate with the risk
• Respond quickly to unplanned events, technical issues
• Operational experience of quality systems in a dynamic manufacturing environment eg SAP, Trackwise, MES
• Full understanding of relevant quality and compliance regulations knowledge of requirements for cGMP, US and EU regulatory requirements
• Conduct, report and display of Quality right first time, audit readiness metrics weekly to ensure continuous audit readiness and cGMP compliance
• Support the spot check/walk-through process of the production lines
• Involved in customer complaint investigation if required
• Support the annual product quality reviews if required

POSITION RESPONSIBILITIES

• Provide Quality support to IPT production teams to ensure cGMP standards are maintained.
• Understanding of sterile manufacturing operations is preferred.
• Ability to learn and utilize computerized systems for daily performance of tasks.
• Ability to prioritize, manage multiple tasks, and meet deadlines.
• Perform timely reviews on batch documentation ( EBR's ) / line clearances/ assist in the resolution of concerns commensurate with the risk.Liaise with other Department representatives to promote improvements in GMP and Quality standards
• Keep abreast of the latest developments from regulatory authorities in relation to Quality Compliance activities
• Comply with our current Manufacturing Division, Quality and EHS Management System requirements, as relevant to commercial operations.
• Foster a culture of continuous improvement by deploying Six Sigma tools and support implementation of Model Area within operations from the start.

Experience

Technical

• Sterile filling processes and equipment and support services experience
• Lean Six Sigma Methodology experience desired

Education

• Degree qualification or equivalent (Science, Engineering, Technical)
• Experience in Sterile Manufacturing

General

• Good organizational skills and attention to detail
• Requires good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.
• Ability to learn and utilize computerized systems for daily performance of tasks.
• Strong influencing skills
• Demonstrable analytical and systematic problem-solving skills

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.