My client is seeking to recruit a Quality Systems Specialist for a period of 12 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.
- 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
- Confident public speaker
- Flexible and motivated
- Ability to achieve targets and milestones