Job Description

JOB DESCRIPTION:

" Support cross functional teams in processing documents (assist in document editing, review, approvals)

Assist in process improvements for Document Control Management/Training processes

Revise SOPs related to Document Control/Training on an as needed basis.

Help to support the management and maintenance the electronic document management system ensuring Controlled Documents are processed in accordance with SOPs including creation, revision, approval, and obsoletion of Controlled Documents.

Help to support the management and maintenance of the training system ensuring new users are trained, accounts are set up appropriately, and the system remains in a state of compliance.

Maintain internal formatting standards and ensure all documentation are formatted accordingly. Formatting may include creating templates, fonts and style, pagination and numbering and any other activities required to achieve document requirements. Contributes to continuous improvement of document templates.

Ensure Document Change Requests are created for document revisions and provide appropriate and applicable information on document revisions; creates Document Change Controls for applicable documents.

Management of the Document Control/Management and Training Program will require administrative duties such as Scanning, organizing, and maintaining documents; Assisting file migrations; Providing support during audits and inspections

" Minimum of 3-5 years\' experience of Quality Assurance experience in the Pharmaceutical/Biotech Industry.

Experience in the use of validated computer systems for management of regulated documents and training, including electronic records and electronic signatures.
Experience with Veeva Vault required.
Experience with ComplianceWire, required.
Experience in maintaining cGMP compliance, preferred.
Excellent organizational skills and the ability to handle multiple priorities and projects.
Excellent communication skills with the ability to interact with all levels throughout the organization.
Strong written and verbal communication skills as well as attention to detail

Zortech Solutions