Orion Group Life Sciences are currently recruiting a Quality Technician on behalf of our Multinational Biopharmaceutical Client based in Carlow on an initial 11-Month contract with potential to extend.
* These are shift roles operating a 4-cycle shift. There is a shift allowance of 33.33%
JOB DESCRIPTION
* Work a 4-shift pattern role
* Technical knowledge of sterile manufacturing processes
* Perform timely reviews of batch documentation/investigations/reports, highlighting and assisting in the resolution of concerns commensurate with risk
* Respond quickly to unplanned events and technical issues
* Operational experience of quality systems in a dynamic manufacturing environment, e.g., SAP, Trackwise, MES
* Full understanding of relevant quality and compliance regulations, including knowledge of requirements for cGMP, and US and EU regulatory requirements
* Conduct, report, and display Quality right-first time and 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 (EBRs), line clearances, and assist in the resolution of concerns commensurate with 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 current 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 practices within operations from the start
QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS
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
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