A QA Document Controller is required for a pharmaceutical in Carlow. The candidate will be responsible for supporting the Quality Department in the management of the site GMP documentation, and in supporting the Quality functions in various administrative duties. Ensure that objectives are effectively achieved, consistent with the company requirements to ensure compliance, safety and reliable supply to our customers.
- Responsible for the control, operation and maintenance of the site Central Documentation Control system
- Be a document system expert; this will include document generation, review, approval and document system work flow expedition e.g. SOP’s, SWI’s, Policies, Monographs.
- Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so.
- Support site activities through documentation generation, filing, tracking, auditing and maintenance of associated databases including Trackwise.
- Establish and effectively manage information management systems, develop reports, presentation, projects, timelines and correspondence utilizing many different computerized systems.
- Use standard systems including MS Word, Excel, PowerPoint, Outlook, SAP and various company and industry specific software such as document tracking, work order entry/tracking, procurement, manufacturing entry/reporting, etc.
- General audit preparation of documentation for audits (i.e. FDA, IMB, Corporate, Customer, etc.).
Presentation, compilation and review of data as directed.
Qualifications & Experience:
- 2 years’ experience of working in a similar Quality Assurance related role in the Pharmaceutical Industry.
- Degree in Science or related discipline preferable.
- Supervisory experience preferable
- Knowledge of EU/US quality related pharmaceutical regulations.
- Basic computer literacy.
- Strong communication skills.
- High level of technical aptitude.
- Demonstrated initiative and pays attention to detail.
- Good presentation skills.
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