Associate, QA Documentation

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: .

Job Summary

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.

Job 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

Job Requirements

• Education
• Education at the post-secondary level
• Knowledge, Skills and Abilities 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)
• Experience
• Preferably 1-2 years of experience in related field of GMP documentation.

At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed.

We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

The hiring range for this position is $42,425.37 - $59,395.52 CAD per year. The final agreed-upon salary may vary based on factors such as job-related knowledge, skills and experience.

We are looking for top talent. If your qualifications differ from those listed above, the scope of work and final agreed-upon salary may be adjusted to reflect your individual qualifications.

The Apotex Total Rewards package goes beyond base salary. Apotex offers bonus programs based on your position in the organization, you can excel based on our pay-for-performance philosophy. With comprehensive benefits, a pension plan to help you save for retirement and learning and development opportunities, we provide a comprehensive package for your personal and professional development.

Apotex will use artificial intelligence to screen, select and/or assess your application for this job.

This job posting is for a role that is currently available and vacant at Apotex.