North York, Ontario

Documentation Specialists – cGMP controlled / pharmaceutical – regulatory requirements

Documentation Specialists – cGMP controlled / pharmaceutical – regulatory requirements
 
Req#: 9762326
 
Documentation Specialist II
x2 positions
Location: Toronto, ON
 
A minimum 3-5+ years’ experience, in a cGMP controlled/ pharmaceutical industry with a demonstrable working knowledge of documentation review / writing, cGMPs and regulatory requirements.
Department: FDA Remediation Cost CA
Job Category: Administrative
Job Title: Documentation Specialist II
 
DUTIES:
 
– Tracking and reviewing change control documentation. Assist with the editing of quality documents (SOP's, guidelines, validation master plans, user requirement specification, etc.) to ensure compliance with regulator requirements.
– Must be able to work quickly with a high degree of accuracy.
– Must possess sound interpersonal and information gathering skills, being able to relate well to others at all levels throughout the organization and have the ability to work in a team environment, effectively interacting with others.
 
Experience: 3 to 6 years.
 
 
Perform a technical GAP assessment between site standards / practices on the shopfloor and technical instructions. Update the technical intructions in order to correct any potential findings.
 
Redesign technical diagrams to increase the clarity.
 
Work with SME to draft or revise documents.
 
Assist with document management in Quality Geode system.
 
Perform quality checks on documents; check styles and formats;
 
ensure all hyperlinks and cross-references are active; Check formatting complies with template requirements.
 
Check spelling; nomenclature and grammar and make appropriate corrections.
 
Follow up on the review and approval process to expedite document approval when necessary.
 
SKILLS:
 
Good knowledge of Microsoft office applications, especially Word and Visio.
 
Must possess excellent communication and organization skills
 
Education and experience:
 
Bachelor’s Degree or Higher in a science-based field.
 
A minimum 3-5+ years’ experience, in a cGMP controlled/ pharmaceutical industry with a demonstrable working knowledge of documentation review / writing, cGMPs and regulatory requirements.

 

Skills and Experience:
 
CGMP
CGMPS
DOCUMENTATION
MICROSOFT OFFICE
ORGANIZATION SKILLS
 
Additional Skills:
VISIO
WORD
CHANGE CONTROL
DOCUMENT MANAGEMENT
MICROSOFT WORD
QUALITY CHECKS
 
Minimum Degree Required: Bachelor's Degree
# of Positions: 2
 
 
 
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