Job Description
Summary: Our client, a biopharmaceutical company located in Waterford, is seeking a QC Documentation Control Specialist. The ideal candidate will play an integral role supporting a Digital Paperless project ensuring the creation, storage, issuance, and retrieval of all documentation in a manner which meets cGMP requirements. This encompasses but is not limited to project tasks and QC day to day activities. 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 procedures. 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. Qualifications & Experience: 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 environment. Working knowledge of computer systems. Project Management skills and experience a distinct advantage. Skills: CGMP Project Management skills Computer system QC documentation management Secretarial