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Details
Senior QA Specialist (hybrid)
Reference: | RK23762 | Location: |
Tipperary |
Qualification: | Degree | Experience: | 5-7 Years |
Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
May be suitable for:
QA Specialist
Senior QA Specialist (hybrid)
RK23762
11 Months
Tipperary
We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Tipperary. 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.
As a Senior QA Specialist, you will be a key driver of quality assurance activities at our site, ensuring that all operations align with cGMP principles and regulatory expectations from agencies such as the FDA and EMEA. You will take ownership of maintaining compliance within your assigned areas, working closely with cross-functional teams to uphold the highest standards of quality and regulatory adherence.
Key Responsibilities:
- Lead the QA review and approval process for Change Controls, Deviations/CAPAs, SOPs, and related documentation, ensuring full compliance with GMP and site-specific requirements.
- Manage QA operational duties related to product disposition, ensuring timely and compliant decision-making.
- Monitor and evaluate new regulatory guidance and industry best practices, assessing their impact on quality systems and driving necessary updates.
- Assist in developing and maintaining QA policies, SOPs, and reports that support site operations and compliance.
- Champion continuous improvement initiatives by identifying opportunities to enhance quality processes and operational efficiencies.
- Participate in risk management activities, applying relevant guidance and industry best practices to mitigate potential quality risks.
- Support and execute the internal audit program, including conducting audits as required to ensure ongoing compliance and improvement.
Education and Experience:
- Degree in Science, Quality, or a related Technical field.
- 5-10 years of experience in Quality Assurance, Quality Control, or Technical Operations within FDA/EMEA regulated environments.
- Hands-on experience with quality management systems such as Veeva, SAP, PAS-X, or similar platforms
If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.
Laboratory Scientist Biopharmaceutical Cork City Dublin Packaging Engineer Product Development Engineer Manufacturing Executive Chemistry Quality Assurance Supply Chain Sales and Marketing PhD Engineering Quality Engineering Scientist Quality Control Academic Project Manager Allied Healthcare Pharmaceutical Mayo Clinical Research Scientific Microbiology IT Medical Affairs Sales and Marketing Medical Device Life Science Limerick Diagnostics Cork Biotechnology Connected Health Supply Chain Pharma Sales Validation Engineer Academic
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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
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