Quality Assurance Technician
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| Job Type | Permanent |
| Area | Dublin |
| Sector | Quality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #2231 |
| Job Views | 1200 |
- Description
- Would you like to join a diverse Quality Assurance Team who value teamwork and collaboration? Team Horizon have an opportunity available with our client, for a Quality Assurance Technician. This role allows you the chance to join a company who change millions of patients of lives with innovate therapies in healthcare and beyond. In this position you will report to the QA Supervisor and be responsible for the safe, compliant, and efficient execution of job duties in a team environment.
Why you should apply:
Join a company that has developed a stand-out culture of innovation, inclusion, and development, and consistently features as a great place to work.
Generous package with good base salary and benefits to including but not limited to health insurance, pension, and bonus.
Join an organisation who uses Innovative new technologies, who embrace diversity, equality and inclusion and puts patients first.
What you will bedoing:
Perform assigned task in accordance with procedural requirements and scheduled timelines. Notify supervisor and other impacted stakeholders if procedural requirements or timelines are not being met.
Understand cGMPs and procedural requirements for your area of responsibility and be a resource to operators and other personnel to ensure compliance to these requirements.
Assess and understand events that may not be in accordance with procedures or cGMPs. Make decisions consistent with job responsibilities, regulations and procedures and policies. Provide appropriate comments to cGMPs documents, when needed. Provide timely feedback and details to supervision and other impacted personnel.
Perform routine review of documentation generated by personnel such as BMRs, logbooks, forms, protocols, reports, COAs, etc.
Author documents that ensure cGMP compliance, such as Standard Operating Procedures, investigations, reports and forms.
Develop and maintain metrics for trends and key performance indicators.
Monitor documentation errors and work with personnel to correct documentation, as needed, and develop preventive actions to reduce or eliminate recurrences.
Draft, review, and approve qualification documentation for production equipment.
Draft, review and approve cleaning validation protocols and reports.
Draft, review and approve Product Quality Reviews.
Draft, review, and approve SOPs, Site Master Files, forms, and other documentation, as required. Track and publish review schedules. Follow-up with authors, reviewers and approvers to assure review schedules are met.
Initiate, facilitate, monitor, trend Change Control, Complaints, Deviations, CAPAs and other Quality System documents as required.
Support and adhere to established processes and productivity targets.
Observe established escalation process for issues impacting established production-related SLAs (Service Level Agreements) and/or fulfillment of production goals.
Provide status updates on own activities and productivity challenges according to defined procedures.
Seek process innovation and continuous process improvement.
Complete and conform to all training requirements for job role, including company-required and job role-specific training.
Carry out and assist in the on-going training of new and existing personnel, as appropriate.
Observe all safety and compliance procedures and actively highlight any safety concerns to help drive the reduction of accidents or near misses.
What you need to apply:
Prior pharmaceutical or quality assurance experience
Knowledge of cGMP requirements and practices preferred.
Strong analytical skills and knowledge of quality systems.
Demonstrated written and verbal communication skills.
Knowledge and Skills:
Computer literate; proficiency in using LIMS systems and Microsoft Office suite
