This position will be required to work collaboratively with all departments to manage and maintain controlled documents within the company's quality management system. This position will require expertise in Microsoft Word and Excel as well as PDF automation tools in Adobe Acrobat Professional.
Responsibility's
- Facilitate the implementation of the document management system
- Assist the System Administrator in performing the daily functions
- Perform a visual quality check of each document and validate the correctness of formatting, styles and compliance with company standards.
- Provide publishing support for company documents, including the use of eCTD format for regulatory submission documents
- Assist in managing and tracking non-conformance events, deviations, CAPAs in the electronic QMS.
- Document and track Change requests as they are initiated
- Create training courses and manage training activities for all QMS personnel
Qualifications
- Associates or bachelor's degree
- 2-3 years of experience in document management in the Pharmaceutical industry
- Working knowledge of GMPs (21 CFR 210/211, 1271 and 810).
- Experience with Change Control practices/strategies
- Proficient in Outlook, MS Word, Excel, Power Point, Adobe Acrobat Professional and other software applications
