QA Specialist
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| Job Type | Fixed Term |
| Area | Dublin, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | 2841 |
| Job Views | 673 |
- Description
- Do you want to be part of a Great Place to Work? Team Horizon is seeking a QA Specialist on behalf of a global, research-based biopharmaceutical company that combines leading-edge biotech with the expertise and capability of an established pharmaceutical leader.
Why you should apply:
There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
Join a company whose goal is to help patients live healthier lives and are proud to be a Great Place to Work.
What you will be doing:
Represent the site Quality Assurance Department as SME in compliance
Manage/input into SAP/POMs refinement initiatives.
Liaise with Site Operations and BTS functions as necessary to support compliance initiatives
Co-ordinate compliance activities for all systems for Manufacturing, Laboratory, and IT areas.
Track and provide relevant quality metrics to Quality Management as required
Perform quality risk assessment of all GMP documentation systems and support stakeholders in the mitigation of compliance risks.
Prioritize risks and work with all site departments to ensure documentation and system compliance be current with regulatory requirements
Ensure alignment between the local and global compliance and QRM initiatives
Ensure all systems, processes and their outcomes comply with standards that meet applicable international and national regulations and guidelines and fulfill company requirements
Write or review and approve protocols, reports and SOP’s to effect compliance gap remediation as appropriate
Initiate action reports or deviation reports for any applicable nonconformance
Seek process innovation and continuous process improvements
Recognize and report to immediate supervisor any issues or deviations from accepted standards
Provide status updates on own activities and productivity challenges according to defined procedures
Complete and conform to all training requirements for job role, including company-required and job role-specific training, Carry out and assist in the ongoing 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
Any other duties as assigned
What you need to apply:
Relevant industry experience including strong knowledge in GMP regulations working in a pharmaceutical, biotechnology or medical device industry
3+ years of experience in a quality assurance role
Experience in compliance requirements including Eudralex, 21 CFR Parts 210, 211, ICH Q9, Q10 and other applicable regulatory requirements
SAP or ERP system experience
Excellent communication and interpersonal skills, including technical writing
Strong analytical and problem-solving skills
Maintain credibility and integrity.
Goal focused
Demonstrate passion and energy
