Quality Assurance Associate – Pharmaceuticals
4 days ago
The Client is an exciting and agile generic pharmaceutical company excited to announce an opening for a Quality Assurance Associate.
Job SpecificationsThe Quality Assurance Associate will be primarily responsible for preliminary review of documents for product release. Quality responsibilities will also include review of executed batch documents and tracking of testing at Third Party labs and tracking of 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 that 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 in compliance with current Health Canada’s GMPs and best industry practices.
- Assist with the recall of any defective products and execute the recall as required by Company policy and Health Canada.
- Responsible for the approval of products intended for destruction.
- Responsible for temperature downloads and defining and executing temperature mapping, when applicable.
- Coordinate with Warehouse staff for incoming product inspection and label review.
- Maintain retain sample inventory for active products and submission samples for future products, including annual retain sample physical inventory.
- Communicate in a timely manner findings related to documentation and release issues, including but not limited to delays in receiving documentation from Contract Fabricators and deviation investigations.
- Review executed batch records.
- Collect and/or review technical records from foreign sites, for example, method and process validation protocols and reports.
- Track stability for commercial and submission lots on an ongoing basis and ensure stability for products to support shelf life is filed.
- Interface with 3rd party and foreign site organizations on GMP matters to resolve quality matters as required and/or meet Canadian GMP requirements.
- Any other duties as assigned by the Senior Director – Drug Safety, Quality & Compliance.
- Knowledge of Canadian GMP’s and all relevant Health Canada Policies and Guidelines.
- 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. Ability to coordinate and manage multiple projects simultaneously.
- Ability to work independently and make decisions based on judgment and integrity.
- Ability to work well under pressure, in a team-based environment.
- Good interpersonal skills; ability to interact with staff, clients, and key stakeholders on all levels.
- Strong problem-solving/analytical ability and issue-resolution skills. Demonstrated ability to respond to and initiate improvements.
- Excellent written and verbal communication skills.
- Proficient user of Microsoft Office products including Excel, Word, PowerPoint, etc.
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