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Job Description
Key member of the QC Luna team responsible for supporting the QC Luna Digital Paperless project, ensuring documentation meets c GMP requirements.
Reporting to the Luna project manager, you will play an integral role in the creation, storage, issuance, and retrieval of all documentation.
Responsibilities
- Define, manage, and maintain a documentation control system for QC projects & BAU c GMP 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 Luna 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.
- Secretarial and/or clerical qualification or accreditation.
- Minimum of 3 years experience in similar role.
- Very good knowledge of c GMP in a regulated environment.
- Excellent accuracy and attention to detail.
- Strong Planning/Organising skill.
- Customer Focus Driven 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.