2023-810-Documentation Control Specialist-Waterford Contractor

This role is on a 10 month contract with a view to extension.

Purpose

Reporting to Our Clients project manager as a key member of the QC team, you will play an integral role in supporting the QC Digital Paperless project ensuring the creation, storage, issuance, and retrieval of all documentation in a manner that meets cGMP requirements. This encompasses but is not limited to QC 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, and support all external audits and any key quality Initiatives.

• Ensure issuance and storage of QC and project documents.

Requirements

• Leaving Certificate or equivalent and will preferably have secretarial and/or clerical qualification or accreditation.

• Minimum of 3 years of experience in similar role.

• Excellent communicator.

• Flexible and adaptable- comfortable and open to change.

• Works well across all levels of the organization.

• Works on own initiative in a self-directed manner with minimal supervision.

• Highly motivated and focuses on achieving results.

• Excellent attention to detail.