Job Highlights
Not Disclosed
Mid-Senior level
Posted 11 months ago
Job details
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
" 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
Benefits Offered?
- No
Bonus Offered?
- No
Travel Required?
- No
Location:
- Canada
Experience:
- Mid-Senior level
Global Experience Needed?
- No
Specialized Experience Needed?
- No
Apply before:
- Apr 17, 2024
Company Overview
Zortech Solutions
Current Openings: 0
The Zor Group is a globally operating conglomerate spanning multiple industries across four countries. Established in 2009 with a mission to make a positive impact, Zor initially began as a staffing organization and naturally evolved into the technology sector. In 2018, ZorTech was introduced. Plans for international expansion were initiated in 2020, leading to successful entry into the US market. Alongside an impressive year-over-year growth rate, we also established an offshore delivery team in the USA & India. With the incorporation of IT Services, ZorTech now offers end-to-end solutions, ranging from top-level talent sourcing to managing large-scale projects. Our organization currently operates in four countries, including Canada, the USA, the Dominican Republic, and India.
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