Coordinator, QAIP QS6-GQC-QAIP RH

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.

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Job Summary

• Responsible for 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
• Responsible to coordinating, with the Supervisor Logistics, training, monitoring and auditing of the receiving sampling and inspection activities performed by Samplers/Material Handlers
• Responsible to ensure that deviations or non-conformances are adequately investigated and documented in order to provide appropriate disposition of materials

Job Responsibilities

• Works in a safe manner collaborating as a team member to achieve all outcomes
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion
• 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
• Have required working knowledge to operate SAP, LIMS, and Trackwise systems

Quality Systems

• Lead investigations and CAPA implementations within the QAIP department and provide support to investigations and implementation of CAPAs to all areas of the business as required
• Review and approve all non-conformances and assist Logistics personnel with troubleshooting/investigating issues related to material receiving process, sampling process and NIR or TruScan analysis as required and work as a team member to achieve all tasks/activities required to adequately investigate and address the non-conformances and prevent reoccurrence
• Generate investigations as an observing department when deviations from established procedures or acceptance criteria are observed

Quality Support

• Audit the work performed by Samplers/Material Handlers during receipt and inspection of incoming material, sampling of material and completion of NIR or TruScan analysis
• Review logistics receiving / sampling and Production documents
• Review and update the manufacturing plant entry in SAP in accordance with manufacturer Certificate of Analysis
• Notify 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 the daily operations of the QAIP Sampling area and Production to ensure rooms and equipment, are used in accordance with GMP and Standard Operating Procedures
• Performs reserve sample inspections and waste disposal as required
• Log in samples into SAP/LIMS and forward the documents/material samples to required labs for testing
• Initiate Change Control for changes related to QAIP process as required
• Ensure that training records are accurate and completed according to cGMP
• Provides training to new Coordinators
• 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 Must be familiar and knowledgeable with GMP and quality requirements Excellent English written and verbal communication skills Good organizational skills and ability to manage time effectively Must be detail-oriented, accurate and reliable Must be able to 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, Access would be an asset
• Experience Minimum one year of relevant experience in a pharmaceutical environment with a Bachelor of Science Degree Minimum of three years of relevant experience in a pharmaceutical environment with a Community College Diploma

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.