QA Systems Technician
This job does not exist anymore.
Try running a new searchor browse our vacancies.
Or fill in the form below to receive job alerts.
| Job Type | Permanent |
| Location | Dublin |
| Area | Dublin, Ireland |
| Sector | QualityOperations & Manufacturing |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #2050 |
| Job Views | 151 |
- Description
- Are you passionate about Quality? Do you have 2 years GMP experience? If the answer is Yes, Team Horizon has an exciting permanent opening for a QA Systems Technician.
You will be based in our Clients OSD manufacturing facility in Dublin and your day-to-day focus will be around Quality Systems (Deviations, CAPAs, PQR, Change Control). You will also be responsible for the review and assessment of data and cGMP documentation generated within the Quality Assurance groups and other departments.
Why you should apply:
Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
The role is generously compensated, and attracts a competitive base salary and highly attractive benefits package.
Excellent career progression opportunities.
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, 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. generated to support commercial and development products for accuracy, completeness, and compliance to GMP and procedural requirements.
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 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:
You will have a relevant a third level Bachelor’s Degree in Chemistry or related Science discipline
1-2 years’ experience in QA/Compliance in pharmaceuticals or related industry.
Knowledge of cGMP requirements and practices preferred.
Strong analytical skills and knowledge of quality systems.
Demonstrated written and verbal communication skills.
