Document Controller

Summary:
A Document Controller is required for a biopharmaceutical company in Waterford. The successful candidate will play an integral role supporting a digital paperless project ensuring the creation, storage, issuance, and retrieval of all documentation in a manner which meets cGMP requirements.

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.

Qualifications & 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.
• Strong Planning/Organising skill.
• Good Presentation skills.
• Working knowledge of computer systems.
• Project Management skills and experience a distinct advantage.