Project Leader, R&D QA Operations

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:   www.apotex.com .

Job Summary

The project Leader, R&D QA Operations is responsible for monitoring the quality of operational aspects related to Formulations Development and New Product Launch processes at the Signet Campus and Etobicoke site.  The Project Leader’s core responsibilities include approval of master manufacturing/packaging records, executed batch records, change control and investigation records for non-commercial batches such as Investigational Medicinal Products (IMPs) in support of regulatory filings.  This role provides leadership and mentoring to junior associates and represents R&D Quality in cross functional meetings.

Job Responsibilities

• Act as the primary R&D QA contact for all product quality issues for non-commercial batches manufactured by Apotex Formulations Development and New Product Launch at Signet and Etobicoke sites

• Review and approve master documentation, protocols/reports, stability protocols and associated change controls from Apotex R&D for non-commercial batches

• Conduct impact analysis of the proposed corrective & preventative actions by engaging Apotex subject matter experts, as required

• Establish and maintain a system to trend investigations and create visibility of quality related issues for Formulations Development and New Product Launch

• Ensure that all manufacturing, packaging and related documents pertaining to the batch are complete, accurate and reviewed and all investigations/deviations have been closed prior to release

• Provide support to R&D to stay abreast of regulatory inspections at their sites and assists in resolution of quality concerns arising from those inspections

• Audit and approve executed batch records for IMPs, registration/submission and demonstration batches

• Review, coordinate and approve activities for deviation investigations and CAPA for R&D operations

• Coordinate and lead complaint investigations for IMPs

• Review and approve R&D change control requests, including new SAP code creations, supplier changes, etc.

• Provides QA approval to allow Formulations Development or New Product Development to proceed with manufacturing based upon preliminary investigation findings and root cause analysis provided all the necessary adjustments have been made to restore equipment/facilities to full operation

• Liaises with internal customers and stake holders to review and discuss deviation root causes and proposed CAPAs for complex investigations and provides QA recommendations regarding actions such as initiating process optimization investigations with R&D operations

• Assist in the preparation activities leading up to regulatory or customer inspections and participate during inspections to address requests

• Review Pharmaceutical Development Reports (PDRs) and other documents required for regulatory applications/submissions

• Perform a final overall quality review of regulatory submission documents to ensure the science/data/conclusions are sound, comply with current regulatory standards, and to ensure that submissions are of high quality, consistent and complete

• Perform a concurrent review of critical submission documentation (e.g. QoS, Batch Records, PDR/CQA/QTPP, validation/stability reports, Specifications/CofA/Release Results, Quality/Lab Investigations, technical reports/summaries) for accuracy, completeness, compliance, appropriate content/justifications, adherence to regulatory guidelines/strategies and commitments

• Represent R&D QA during cross functional meetings as required, including Global Project Management meetings and Product Launch meetings

• Assist in training and mentoring junior members of the team where required

• 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

• B.Sc. in Chemistry or Biochemistry or in a related science

• Knowledge, Skills and Abilities

• Knowledge of GMP and cGMPs requirements

• Experience with solid dose manufacturing techniques

• Knowledge of Microsoft Office programs and laboratory LIMS systems an asset

• Ability to effectively work both independently and in a team environment

• Superior time management and organizational skills

• Experience with technical report writing and scientific documents an asset

• Clear and concise written and oral English communication skills

• Experience

• Minimum of 5 years of experience in the pharmaceutical industry, 2 years in Quality Assurance

At Apotex, we are committed to fostering a welcoming and accessible 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 $83,958.00 - $139,930.00 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.