QC Documentation Specialist

Role Summary:

• A new vacancy exists for a QC Documentation Specialist to join our client’s biopharmaceutical facility in Co. Waterford.
• Reporting to the Project Manager as a key member of the QC team, you will play an integral role supporting the QC 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 project tasks, QC day-to-day activities.

Core Duties and 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, support all external audits and any key quality Initiatives.
• Ensure issuance and storage of QC and Projects documents.

Minimum Qualifications and Experience:

• 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 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
• 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

Please note, we do not require agency assistance with this role.