PE Global is currently recruiting for a QA Specialist on behalf of our client based in Carlow:
11 month initial contract – Work a 4 shift pattern role
The Quality Assurance Specialist is required to
- 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.
Qualifications, Skills & Experience Required
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
People
- Focus on Customers and Patients
- Collaborate
- Act with Candour and Courage
- Make Rapid, Disciplined Decisions
- Drive Results
- Demonstrate Ethics and Integrity
Interested candidates should submit an updated CV.
Please click the link below to apply, call Audrey on 0214297900 or alternatively send an up to date CV audrey.mccarthy@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
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