Job Description
Job Summary: The QC Luna team is seeking a highly organized and detail-oriented individual to support the creation, storage, and retrieval of documentation in a regulated environment. Reporting to the Luna project manager, you will play a key role in ensuring the QC Luna Digital Paperless project meets cGMP requirements. As a member of the QC Luna team, you will be responsible for: • Defining, managing, and maintaining a documentation control system for QC projects and BAU cGMP documents. • Managing, indexing, and controlling QC on-site and off-site documents. • Creating and maintaining QC procedures. • Training QC site personnel on documentation management processes and QC Luna project implementation. • Defining, managing, and maintaining QC project key metrics to ensure site visibility and strong internal customer satisfaction. • Supporting Product Performance Reviews (PPR) and providing information to support continuous improvement activities. • Reporting right-first-time documentation findings to support continuous improvement initiatives. • Participating in internal audits and supporting external audits and quality initiatives. • Ensuring the issuance and storage of QC and project documents. Essential Requirements: • Qualification: Leaving Certificate or equivalent, preferably with secretarial and/or clerical qualification or accreditation. • Experience: Minimum of 3 years in a similar role. • Skills and Knowledge: + Very good knowledge of cGMP in a regulated environment. + Excellent accuracy and attention to detail. + Strong planning and organizing skills. + Customer-focused with excellent interpersonal skills. + Good presentation skills. + Working knowledge of computer systems. + Personal development and goal management skills. + Project management skills and experience a distinct advantage. • Personal Characteristics: + Excellent communicator. + Flexible and adaptable, comfortable with change. + Works well across all levels of the organization. + Works independently with minimal supervision. + Highly motivated and focused on achieving results. + Excellent attention to detail.