Technician, QAIP Mfg QS6-GQC-IPSP S

Job Description

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

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

Responsible for review and verification of all Master Manufacturing Records to ensure completeness and accuracy as per established Apotex and GMP standards.

Responsible for transaction verification and result recording in SAP and LIMS to allow for batch disposition from QA In Process (QAIP) to QA Product Release.

Job Responsibilities

Review all Master Manufacturing Records to ensure quality products are manufactured according to established standards and procedures.
Performs verification of potency calculation in Master Manufacturing Record as required.
Performs results recording in SAP and LIMS where applicable.
Provides recommendations for quality issues identified and the appropriateness of action(s) taken for resolution in relation to Master Manufacturing Record issues.
Responsible to initiate Shelf Life Extension (SLED) requests and completion of F-notification reports related to process yield. Ensure that all F notifications are clearly and appropriately documented in order to make products disposition decision according to Apotex established standards.
Track status of outstanding investigations (PRs)/F-notifications to ensure that batches are being processed through Supply Chain in a timely manner.
Acts as a backup to QAIP Manufacturing Technician (QS5) and is able to perform all required duties of QAIP Manufacturing Technician (QS5).
Supports Supervisor in training of new hires.
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.
All 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
Excellent organizational skills and the ability to manage time effectively
Ability to follow instructions according to written procedures
Ability to manage multiple priorities in a fast-paced and changing environment
A knowledge of GMP is required
Familiarity with Word, Excel, Access is an asset

Experience:
2-3 years of relevant working experience in pharmaceutical industry
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 $55,138.14 to $ 77,193.40 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.