Specialist - Knowledge Management Operation - Pharma

Specialist - Knowledge Management Operation

Responsibilities:

- Support the implementation of updated Quality Management System (QMS) documents (e.g. SOPs, Work Instructions, etc.)

- Provide support for global, and local, audits and inspections by providing employee qualification records, retrieving effective documents from the Documentation Management System (DMS), and addressing identified gaps in our global Documentation and Training Management materials.

- Support company-wide or Global Quality & Regulatory Affairs programs and strategic projects focused on improved documentation and training systems.

- Pull training performance metrics, KPIs, and other performance indicators to assess the health of the Knowledge Management system.

- Support global training management systems initiatives (DMS and LMS) locally.

Key Duties and Responsibilities:

- Support the creation, implementation, and measuring effectiveness of QMS documents and training programs.

- Partner with GQRA and functional stakeholders to support audits and inspections via collection of impacted qualification records and QMS documents.

Job Posting Qualifications:

- Education: Bachelor's/Master's Degree from accredited institution

- 3- 5 years' of administrator experience supporting a Documentation Management System (DMS) and/or Learning Management System (LMS) in a regulated environment.

- Experience working for a pharmaceutical, medical device, or other regulated organization is preferred.

- Experience using MS Office Suite (Outlook, Word, Excel, PowerPoint, Edge.) is preferred.