Quality Assurance

Quality Assurance (QA) Specialist (English/French)

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.

Job Responsibilities

- Incoming Material and Finished Product Release

- Perform the verification of all documents required to release incoming materials for use in production, where and when applicable

- Perform the verification of all documents required to release finished products.

- When applicable, request additional testing samples or perform any additional steps required to evaluate the quality of the product/material.

- When applicable, ensure that product stability studies are initiated and conducted at appropriate intervals and that documentation is available at Searchlight.

- Quality Complaint Handling and APQR

- Log, track and evaluate the quality complaints and ensure adequate communication and timely follow ups with clients and suppliers

- Work with the assigned third party for Adverse Event reporting

- Ensure adequate investigation

- Define appropriate CAPAs

- Track, evaluate and dispose of products returned by the clients where applicable

- Schedule, request, perform and complete annual product quality reviews as per internal procedure and in collaboration with other Searchlight departments and suppliers

- Quality Events, CAPA and Change Control Handling

- Ensure timely creation, tracking and closure of quality events, CAPA and change control

- Perform or assist other departments in problem identification, immediate actions, root cause analysis and CAPA identification

- Track related quality system key performance indicators (KPI)

- Train employees on quality systems program

- Review closed quality events, CAPA and change control, and ensure proper documentation

- Document Control

- Ensure timely review and implementation of SOPs and other QMS documentation

- Ensure master product documentation is available and current per internal procedure

- Follow up and ensure quality events are processed according to required timelines

- Others

- Any other tasks as required by the QA manager or delegate.

- Responsible for reporting adverse events associated with Searchlight products.

- Autres

- Toute autre tâche demandée par le responsable AQ ou son délégué

- Responsable de la déclaration des événements indésirables associés aux produits Searchlight

Job Requirements

- EDUCATIONAL & TRAINING REQUIREMENTS:

- REQUIRED:

- Minimum B.Sc. in sciences or closely related pertinent technical discipline

- Knowledge of Good Manufacturing Practice (GMP) requirements

- ASSET:

- Certificate in Quality Assurance

- Knowledge of regulatory establishment licensing requirements

- EXPERIENCE:

- REQUIRED:

- Minimum of 3 years progressive experience in QA in a GMP environment, in the pharmaceutical industry, or closely related industry

- KNOWLEDGE & SKILLS REQUIREMENTS:

- Detail oriented, accurate and reliable

- Ability to make sound quality decisions

- Good written and verbal communication skills in both English and French

- Ability to work in a dynamic environment with changing priorities and/or defined/tight timelines

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.

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