Job Description
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. 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. 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. Contact: If you would like to learn more about the vacancy, apply now, or contact Thaissa Torres on or . Skills: GMP Communication Writing