Associate, QA Documentation

Apotex•Brantford, ON

2d•CA$42,425 - CA$59,396•Onsite

About The Position

The QA Documentation QS4 works as a member of the QA department and carries out work related to documentation activities, maintaining accurate and organized records and documentation for the department and site.

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)

Nice To Haves

Preferably 1-2 years of experience in related field of GMP documentation.

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; second checks for accuracy and authenticity of records issued by other personnel
Maintains QU GMP document storage areas: Oversees orderly retention and security of all master and executed documentation (records and logbooks); archives GMP records, logbooks, documents in a labeled, organized manner that enables efficient retrieval; maintains indexes and electronic information copies
Identifies documentation that has reached end of retention period; provides list for management approval prior to arranging for destruction; oversees actual destruction of documentation
Maintains, develops or improves QA document systems to support continued quality improvement
Prepares and issues logbooks according to approved procedures
Routes documents for approval
Coordinates preparation of GMP documents for external distribution
Files completed training for the QA group; supports annual review of QA department training curricula and histories
Oversees the periodic SOP review program for the company
Completes Change control activities which may include: Authors and peer reviews change controls; ensures completeness, accuracy, and timely provision meeting business needs
Processes Change Control requests; ensures accurate documentation, impacts, and requirements are satisfied; ensures relevant training is completed as assigned
Monitors and reports on the performance and status of the change control and document management systems; tracks outstanding change controls and action items, works with assignees towards completion
Prepares and organizes documents for customers and during audits
Liaises with higher level QU personnel to learn and acquire a fundamental understanding of departmental and regulatory practices; may liaise with other employees in departments across the organization to ensure proper information is contained in all documents
Works in a safe manner collaborating as a team member to achieve all outcomes
Demonstrate Behaviours that exhibit our organizational Values: Integrity, Courage, Teamwork, and Innovation
Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies
All other relevant duties as assigned