Document Coordinator

My client is seeking to recruit a Document Coordinator for a period of 6 months, based in Dublin, responsible for supporting the implementation of quality systems within the Global External Manufacturing organization.

Responsibilities will include (but not limited to):

• Maintain the document management system as required including management of templates, allocation of document numbers and review of draft documents.
• Authoring, review and approval of Quality Systems related procedures
• Supports the ExM team for preparing for area and regional Quality Council meetings in addition to provision of relevant information/metrics for presentation
• Supports the Deviation Management process as per the ExM procedures, facilitating the Investigation Review Board
• Support Quality Systems Specialists in management of the quality systems as required.
• Act as the primary point of contact for the storage of Quality Documents within the ExM Document Archive
• Compiling and performing GMP training to all ExM personnel, when appropriate.
• Support the management of quality documents (SOPs, Quality agreements, templates, forms) and records and maintain associated trackers as required.
• Support the on boarding of new personnel.
• Quality systems Framework Champion, facilitate the timely review of Corporate Quality System Framework directives/SOPs and policies and co-ordinate responses back to HQ.
• Author, track and make obsolete QSF document exception requests as required
• Facilitate the timely ExM review of regulatory inspection observations from other sites for site compliance.
• Collate metrics on a monthly basis.
• Prepare trend and status reports as required.
• Prepare and update training documents, courses and assessments. Deliver training to all relevant site personnel.

Qualifications and Experience required:

• Preferably a degree in Chemistry or Engineering or Science related Degree.
• A working knowledge of Quality Systems, preferably FDA or EU GMP
• A minimum of 2 years' experience in an API or Drug product environment, 1 of which must be in a quality systems or related role.

Essential

• Good time management and organisational skills
• Ability to multi-task numerous projects
• Ability to work with initiative
• Good interpersonal skills
• Good communication and presentation skills

Desirable

• Confident public speaker
• Flexible and motivated
• Ability to achieve targets and milestones