Coordinator, QAIP

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 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.

Job Summary

• Ensuring that all incoming raw materials, packaging components and packaged products are inspected and sampled in accordance with Good Manufacturing Practices and established Standard Operating Procedures.


• Coordinating with the Supervisor Logistics the training, monitoring and auditing of the receiving sampling and inspection activities performed by Samplers/Material Handlers.


• Investigating and documenting deviations or non‑conformances and providing appropriate disposition of materials.

Job Responsibilities

• Works in a safe manner collaborating as a team member to achieve all outcomes.


• Demonstrates behaviours that exhibit our organizational values: Collaboration, Courage, Perseverance, and Passion.


• Ensures 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.


• Has required working knowledge to operate SAP, LIMS, and Trackwise systems.

Quality Systems

• Leads investigations and CAPA implementations within the QAIP department and supports investigations and implementation of CAPAs to all areas of the business as required.


• Reviews and approves all non‑conformances and assists Logistics personnel with troubleshooting/investigating issues related to material receiving process, sampling process, and NIR or TruScan analysis as required.


• Generates investigations as an observing department when deviations from established procedures or acceptance criteria are observed.

Quality Support

• Audits the work performed by Samplers/Material Handlers during receipt and inspection of incoming material, sampling of material and completion of NIR or TruScan analysis.


• Reviews logistics receiving/sampling and Production documents.


• Reviews and updates the manufacturing plant entry in SAP in accordance with manufacturer Certificate of Analysis.


• Notifies Supplier Quality/Procurement departments to update SAP Master Data (i.e. Material Storage Condition) when discrepancy is observed during material receiving process.

QAIP Support Activities

• Oversees daily operations of the QAIP Sampling area and Production to ensure rooms and equipment are used in accordance with GMP and SOP.


• Performs reserve sample inspections and waste disposal as required.


• Logs samples into SAP/LIMS and forwards the documents/material samples to required labs for testing.


• Initiates change control for changes related to QAIP process as required.


• Ensures that training records are accurate and completed according to cGMP.


• Provides training to new Coordinators.


• Performs all other relevant duties as assigned.

Job Requirements

Education

• Bachelor of Science Degree from a recognized educational institution in a related field or Community College diploma in a related field.

Knowledge, Skills and Abilities

• Familiar with GMP and quality requirements.


• Excellent English written and verbal communication skills.


• Good organizational skills and ability to manage time effectively.


• Detail‑oriented, accurate and reliable.


• Can work independently with minimal supervision.


• Proven analytical and problem‑solving skills.


• Ability to manage multiple priorities in a fast‑paced and changing environment.


• Familiarity with Word, Excel and Access is an asset.

Experience

• Minimum one year of relevant experience in a pharmaceutical environment with a Bachelor of Science Degree.


• Minimum three years of relevant experience in a pharmaceutical environment with a Community College Diploma.

At Apotex, we are committed to fostering a welcoming and accessible work environment, where 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.

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