QA Technician Systems
Job ID: JOB-11656
QA Technician Systems
• 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.
• 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.
• You will have a relevant third level Bachelor’s Degree in Chemistry or related Science discipline Technical Skills and Experience:
• 1-2 years’ experience in QA/Compliance in pharmaceuticals or related industry.
• Prior pharmaceutical or quality assurance experience preferred but not required.
• Knowledge of cGMP requirements and practices preferred.
• Strong analytical skills and knowledge of quality systems.
• Demonstrated written and verbal communication skills.
For further information on this role please contact Tommy McKeown on 086 0100903 / firstname.lastname@example.org Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/ Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.
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