QC Documentation Specialist
Waterford, Ireland
Life Science
Fix Term Contract
Posted on:
October 7, 2024
The Highlights:
- Joining a well - established team
- Working with clinical and commercial products
- Great Workculture and Approachable management
The Role:
Elusav Recuitment have an exciting opportunity for a QC Documentation Specialist with a leading global biopharma company in Waterford, Ireland.
Reporting to the project manager as a key member of the QC team, you will play an integral role supporting the QC Digital Paperless project ensuring the creation, storage, issuance, and retrieval of all documentation in a manner which meets cGMP requirements.
Job Responsibilities:
- Define, manage, and maintain a documentation control system for QC projects & BAU cGMP documents.
- Manage, index, and control the QC on-site and off-site documents.
- Create and maintain QC.
- Train QC site personnel on the Documentation Management Processes and QC project implementation.
- Define, manage, and maintain QC project key metrics ensuring site visibility, strong internal customer satisfaction and trending to support continuous improvement activities.
- Supporting and providing appropriate information to support Product Performance Reviews (PPR).
- Support and report right first-time documentation findings to support continuous improvement initiatives.
- Participate in internal audits, support all external audits and any key quality Initiatives.
- Ensure issuance and storage of QC and Projects documents.
Job Requirements:
- Leaving Certificate or equivalent and will preferably have secretarial and/or clerical qualification or accreditation.
- Minimum of 3 years experience in similar role.
- Very good knowledge of cGMP in a regulated.
- Excellent accuracy and attention to detail.
- Project Management skills and experience a distinct advantage.
If you would like to learn more about the vacancy, apply now, or contact Thaissa Torres on ttorres@elusav.com or +35315822807.
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QC Documentation Specialist
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