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Details
Quality Systems Specialist
Reference: | AMC21195 | Location: |
Dublin |
Qualification: | Degree | Experience: | 5-7 Years |
Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
May be suitable for:
Quality Systems Specialist
Quality Systems Specialist
AMC21195
Contract – 11 months
Swords
We’re currently recruiting for an exciting opportunity with a Biopharmaceutical organization based in North Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Job Purpose:
The Quality Systems Specialist plays a vital role in maintaining and enhancing the company’s Quality Management System, ensuring alignment with company requirements to uphold compliance, safety, and consistent supply to customers.
Primary Responsibilities:
- Provide quality support to projects and sites, offering training and guidance on the interpretation and implementation of company Guidelines/Policies and regulatory standards.
- Specialize in deviation management, change control management, quality systems management, document/SOP management, and GMP training & knowledge management.
- Ensure the health and effectiveness of the Quality Management system at the site, taking timely actions to meet compliance and production requirements.
- Assist in metrics management for site deviation and change control systems.
- Review and approve site deviation and investigation reports.
- Support the site change management process.
- Identify root causes of deviations and implement corrective actions, demonstrating basic knowledge of six sigma, LEAN, and root cause analysis tools.
- Manage day-to-day Deviation CAPA and Change Control metrics.
- Oversee the quarterly deviation trending process and annual trending at the site.
- Collaborate with cross-functional departments to meet change control and deviation management system requirements.
- Assist in Regulatory and Compliance Inspections at the site as necessary.
- Support recall management activities.
- Adhere to company Global and regulatory requirements, executing current Good Manufacturing Practices (cGMP) in all applicable job functions.
- Foster a Quality culture focused on delivering uninterrupted supply and Right First Time service to patients.
Minimum Education/Experience:
- Bachelor’s degree (or higher) in Chemistry, Biology, Microbiology, Automation, Engineering, or equivalent.
- 5 years’ experience in Quality Control, Quality Assurance, Pharmaceutical, Vaccine, or Biological Operations, or Technical Operations.
- Proficient knowledge of relevant Quality and Compliance Guidelines (cGMP, Auditing, Quality Management Systems, Quality Agreements, Regulatory Affairs, Training) and associated regulations.
- Experience with new product introductions and/or process qualification/technology transfer.
If you're passionate about quality and compliance and thrive in a collaborative, fast-paced environment, we'd love to hear from you! Please feel free to contact Angela McCauley on +353 (0)87 693 0951 or [email protected] for further information.
Laboratory Scientist PhD Connected Health Clinical Research Limerick Quality Assurance Packaging Engineer Academic Academic Sales and Marketing Medical Device Cork City Biopharmaceutical Allied Healthcare Validation Engineer Medical Affairs Quality Control Diagnostics Mayo Project Manager Product Development Engineer Cork Scientific Biotechnology Supply Chain Sales and Marketing IT Dublin Engineering Microbiology Scientist Pharma Sales Chemistry Supply Chain Manufacturing Executive Life Science Pharmaceutical Quality Engineering
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
Valid XHTML - CSS