Purpose

Reporting to the Luna project manager as a key member of the QC Luna team, you will play an integral role supporting the QC Luna 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 QC Luna project tasks, 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 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 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.
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.