QA Documentation QS4 member carrying out documentation activities at Apotex. Responsible for maintaining accurate and organized records for Quality Assurance department.
Responsibilities
Issues batch and other records and controlled copies of master documents to support manufacturing
Updates corresponding electronic files
Ensures reconciliation of controlled documents or recall of official copies of retired documents
Maintains QU GMP document storage areas
Archives GMP records, logbooks, documents in a labeled, organized manner
Identifies documentation that has reached end of retention period
Maintains, develops or improves QA document systems
Prepares and issues logbooks according to approved procedures
Completes Change control activities
Prepares and organizes documents for customers and during audits
Requirements
Education at the post-secondary level
Good practical experience in document archiving and control
Uses sound technical judgement in making decisions
Good written, oral communication skills and attention to detail
Good organizational, multi-tasking and planning skills
Proficiency in computer applications (i.e. Word, Excel)
Preferably 1-2 years of experience in related field of GMP documentation.
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