Quality assurance Pharmaceuticals ( Hybrid )

Mississauga - Canada

Monthly Salary: CAD 60 - 65

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Primary Functions:

The Quality Assurance Associate will be primarily responsible for the preliminary review of documents for product release. Quality responsibilities will also include reviewing executed batch documents and tracking testing at third-party labs and stability data.

Responsible for the timely coordination of finished product testing and review of required quality documentation for the release of finished products to market ensuring all GMP documentation is correct and compliant.
Ensure SOPs for all applicable elements of product importation distribution testing warehousing and quality assurance are followed and compliant with current Health Canada GMPs and best industry practices.
Assist with the recall of any defective products and execute recalls as required by company policy and Health Canada.
Approve products intended for destruction.
Perform temperature downloads and define and execute temperature mapping when applicable.
Coordinate with warehouse staff for incoming product inspection and label review.
Maintain retain sample inventory for active and submission products including conducting annual physical inventory of retain samples.
Communicate in a timely manner regarding documentation and release issues including delays in receiving documentation from contract fabricators and deviation investigations.
Review executed batch records.
Collect and/or review technical records from foreign sites such as method and process validation protocols and reports.
Track stability for commercial and submission lots on an ongoing basis and ensure stability data supporting shelf life is properly filed.
Interface with third-party and foreign site organizations on GMP matters to resolve quality issues and meet Canadian GMP requirements.
Perform any other duties as assigned by the Senior Director Drug Safety Quality & Compliance.

Requirements

Skills and Qualifications:

Knowledge of Canadian GMPs and all relevant Health Canada policies and guidances.
Bachelor of Science in a science-related discipline; postgraduate training in Pharmaceutical Quality Studies is an asset.
Works independently with minimal supervision and is decisive by nature.
Meticulous and detail-oriented.
Strong organizational and time management skills with the ability to coordinate and manage multiple projects simultaneously.
Ability to work independently and make sound decisions based on judgment and integrity.
Thrives under pressure and performs effectively in a team-based environment.
Strong interpersonal skills with the ability to interact professionally with staff clients and key stakeholders at all levels.
Strong problem-solving and analytical abilities with a demonstrated capacity for issue resolution and process improvement.
Excellent written and verbal communication skills.
Proficient in Microsoft Office applications including Excel Word and PowerPoint.

Required Skills:

Skills and Qualifications: Knowledge of Canadian GMPs and all relevant Health Canada policies and guidances. Bachelor of Science in a science-related discipline; postgraduate training in Pharmaceutical Quality Studies is an asset. Works independently with minimal supervision and is decisive by nature. Meticulous and detail-oriented. Strong organizational and time management skills with the ability to coordinate and manage multiple projects simultaneously. Ability to work independently and make sound decisions based on judgment and integrity. Thrives under pressure and performs effectively in a team-based environment. Strong interpersonal skills with the ability to interact professionally with staff clients and key stakeholders at all levels. Strong problem-solving and analytical abilities with a demonstrated capacity for issue resolution and process improvement. Excellent written and verbal communication skills. Proficient in Microsoft Office applications including Excel Word and PowerPoint.

Primary Functions: The Quality Assurance Associate will be primarily responsible for the preliminary review of documents for product release. Quality responsibilities will also include reviewing executed batch documents and tracking testing at third-party labs and stability data.Responsible for the ...

Primary Functions:

Responsible for the timely coordination of finished product testing and review of required quality documentation for the release of finished products to market ensuring all GMP documentation is correct and compliant.
Ensure SOPs for all applicable elements of product importation distribution testing warehousing and quality assurance are followed and compliant with current Health Canada GMPs and best industry practices.
Assist with the recall of any defective products and execute recalls as required by company policy and Health Canada.
Approve products intended for destruction.
Perform temperature downloads and define and execute temperature mapping when applicable.
Coordinate with warehouse staff for incoming product inspection and label review.
Maintain retain sample inventory for active and submission products including conducting annual physical inventory of retain samples.
Communicate in a timely manner regarding documentation and release issues including delays in receiving documentation from contract fabricators and deviation investigations.
Review executed batch records.
Collect and/or review technical records from foreign sites such as method and process validation protocols and reports.
Track stability for commercial and submission lots on an ongoing basis and ensure stability data supporting shelf life is properly filed.
Interface with third-party and foreign site organizations on GMP matters to resolve quality issues and meet Canadian GMP requirements.
Perform any other duties as assigned by the Senior Director Drug Safety Quality & Compliance.

Requirements

Skills and Qualifications:

Knowledge of Canadian GMPs and all relevant Health Canada policies and guidances.
Bachelor of Science in a science-related discipline; postgraduate training in Pharmaceutical Quality Studies is an asset.
Works independently with minimal supervision and is decisive by nature.
Meticulous and detail-oriented.
Strong organizational and time management skills with the ability to coordinate and manage multiple projects simultaneously.
Ability to work independently and make sound decisions based on judgment and integrity.
Thrives under pressure and performs effectively in a team-based environment.
Strong interpersonal skills with the ability to interact professionally with staff clients and key stakeholders at all levels.
Strong problem-solving and analytical abilities with a demonstrated capacity for issue resolution and process improvement.
Excellent written and verbal communication skills.
Proficient in Microsoft Office applications including Excel Word and PowerPoint.