Elusav Recruitment has 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.
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 documentation.
* 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.
* Support and provide 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 project documents.
Requirements
* Leaving Certificate or equivalent and preferably have a secretarial and/or clerical qualification or accreditation.
* Minimum of 3 years experience in a similar role.
* Very good knowledge of cGMP in a regulated environment.
* Excellent accuracy and attention to detail.
* Project Management skills and experience are a distinct advantage.
Contact
If you would like to learn more about the vacancy, apply now, or contact Thaissa Torres.
Skills
* GMP
* Communication
* Writing
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Administrative and Support Services
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