Qc Documentation Specialist Job In Waterford

QC Luna Documentation Specialist

Support the QC Luna project manager in ensuring the creation, storage, issuance, and retrieval of all documentation in a regulated environment.

Key Responsibilities:

• Define, manage, and maintain a documentation control system for QC projects and cGMP documents.
• Manage, index, and control on-site and off-site documents.
• Create and maintain QC procedures.
• Train site personnel on documentation management processes and QC Luna project implementation.
• Define, manage, and maintain QC project key metrics.
• Support Product Performance Reviews (PPR).
• Support continuous improvement initiatives.
• Participate in internal audits and external audits.
• Ensure issuance and storage of QC and Projects documents.

Essential Requirements:

• Leaving Certificate or equivalent.
• Minimum of 3 years experience in a similar role.
• Very good knowledge of cGMP in a regulated environment.
• Excellent accuracy and attention to detail.
• Strong planning/organizing skills.
• 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.

Personal Characteristics:

• Excellent communicator.
• Flexible and adaptable.
• Works well across all levels of the organization.
• Works on own initiative in a self-directed manner.
• Highly motivated and focused on achieving results.