About Apotex Inc.

Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world.

Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally.

Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.

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Job Summary

Provide Quality support and oversight of manufacturing areas to ensure compliance with Apotex Quality Systems requirements and Good Manufacturing Practices.

Responsible for inspection and physical testing on samples taken from manufacturing to ensure that in process products conform to established standards and regulatory requirements.

Job Responsibilities

• Provides Quality Assurance support and oversight of Manufacturing Processing areas, through Shop Floor engagement (Floor Presence, Functional Area Audits, Compliance Meeting participation, Online batch record review, as applicable).
• Responsible for the execution of quality checks (startup approval, in process and end of batch checks, AQL inspections and Special Testing Request (STR).
• Prepares composite samples (laboratory and reserve); delivers samples to required area(s) and controls storage and disposition of reserve samples.
• Provides immediate direction for potential quality issues on the shop floor including first assessment of potential deviations and initial determination of product impact, containment, immediate corrective actions and escalation.
• Supports the investigative phases related to manufacturing process events, and implementation of Corrective and Preventive Actions (CAPAs).
• Responsible for the daily calibration of all QAIP Manufacturing instruments and coordination with the Electrical Instrumentation group for any internal and external calibration.
• Performs verification of potency calculation of Master Manufacturing Record as required.
• Responsible to perform regular assessments of manufacturing areas to ensure all activities performed in the area are in full compliance with GMPs, SODs and established safety standards.

Ensure all observations are addressed in a timely manner.

• Audits logbooks used in the manufacturing areas for completeness and GMP compliance.
• 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.

Perform other relevant duties as assigned.

Job Requirements

Education

A college diploma / university degree in Pharmaceutical Technology / Chemistry or related sciences

Knowledge, Skills and Abilities

A good command of the English language, both written and verbal

Ability to follow instructions according to written procedures

Very good interpersonal skills required

A knowledge of GMP is an asset

Ability to work shifts when required

Familiarity with Word, Excel, Access is an asset

Experience

A minimum of two years of experiences in a pharmaceutical and / or production environment

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers 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.