Job Summary
The QA Consultant is responsible for QA and regulatory activities related to the importation and distribution of Client drug and natural health products as well as active pharmaceutical ingredients and medical devices at Accuristix Inc. The QA Consultant is also responsible for QA and regulatory activities when Accuristix Inc acts as Canadian QA for a Client. The QA Consultant is required to develop and promote procedures and initiatives to ensure compliance to Health Canada regulations and GMP related to such activities by Accuristix Inc.
Specific Duties
Regulatory and QA
- Maintain regulatory licenses (Establishment License, Site License, Medical Device Establishment License) for Accuristix Inc for activities related to importation & distribution of drugs, natural health products, active pharmaceutical ingredients and medical devices. Ensure terms stated in the licenses are observed. Ensure activities, product categories, dosage forms and other information related to regulatory licenses are accurate and updated as required following Health Canada regulations.
- Maintain Client regulatory licenses as applicable and following terms of contract with Accuristix Inc.
- Obtain & review GMP evidence for foreign sites. Take appropriate actions if regulatory concerns are identified for foreign or Canadian sites. Ensure foreign sites meet compliance requirements.
- File changes with Health Canada to ensure accuracy of regulatory licenses.
- Ensure Accuristix Inc procedures are written and implemented to meet the requirements of Health Canada regulations pertaining to regulatory licenses and related to importation & distribution activities as well as Canadian QA.
- Ensure all required documents are obtained and reviewed to ensure drugs, natural health products, active pharmaceutical ingredients or medical devices can be imported and distributed in Canada following Health Canada regulations.
- Ensure required product manufacturing/packaging/cleaning & testing methods validation evidence is obtained by Accuristix Inc and reviewed.
- Ensure a qualified Canadian laboratory is used for testing of drugs, natural health products, active pharmaceutical ingredients in Canada and required methods have been successfully transferred to this laboratory.
- Inform Client of any missing or concern with documentation that may impact the release of a product lot or batch in Canada or may lead to a recall.
- Execute product batch or lot document review and release of product lot or batch in Canada as prescribed by Health Canada regulations and Accuristix Inc procedures. Hold release of product lot or batch if concerns are identified and inform Accuristix Inc QA Management and the Client QA.
- Identify the need to initiate a product recall in Canada and inform Accuristix Inc QA Management and Client QA.
- Work with the Client to complete product/device recall documentation and file with Health Canada within the prescribed timeline. Ensure required recall updates & recall closure documents are filed with Health Canada.
- Ensure product stability program & testing is executed by the Client and Accuristix Inc reviews product stability data for each time point. Escalate any issues to Accuristix Inc QA Management and Client QA.
- Ensure Quality Agreements are executed between Accuristix Inc and the Client as well as with all manufacturers/packagers/labelers/testers/storage sites & carriers involved in the product/device supply chain.
- Perform or coordinate vendor/contractor audits.
- Ensure the product/device is stored & transported following labeled conditions. Take action with reported temperature excursions.
- Report product complaints/problems to the Client and participate in investigation. Report adverse events/problems immediately to the Client and QA Management. Ensure Health Canada is notified of such as required by the regulations.
- Work with the Client to generate the product APQR or other annual reports required by Health Canada regulations and submit to Health Canada.
- Escalate any regulatory non-conformances to QA Management.
- Maintain all regulatory & QA documents related to importation/distribution of products, active pharmaceutical ingredients & medical devices at Accuristix Inc and ensure these meet the requirement of data integrity (Attributable, Legible, Contemporaneous, Original, Accurate).
- Provide training to QA Associates and other employees as required.
- Conduct and participate in self-inspections ensuring observations are addressed.
- Host and participate in external audits including Clients and regulatory audits. Participate in addressing audit observations.
- Respond to Client inquiries and requests.
- Participate in Client meetings as needed.
- Participate in projects which require QA input.
Other Duties
- Promotes & champions all Quality systems and GMP requirements at the site.
- Ensure Accuristix Inc procedures, regulatory guidelines and Client specific requirements are followed.
- Respond to incidents at the site impacting quality including during off hours. Escalate critical issues to QA & Operations management.
- Initiate deviations when applicable and following Accuristix Inc procedure. Lead deviation investigations. Ensure deviation reports are forwarded to Clients as applicable.
- Initiate & review Change Controls supporting changes impacting importation/distribution/Canadian QA activities.
- Assist in product recalls.
- Approve destruction of GMP documents.
- Maintain current knowledge of Health Canada regulations pertaining to QA and GMPs especially with regulatory licenses and product/device importation & distribution.
- Generate metrics.
- Perform other duties as required.
Qualifications and required skills:
- Bachelor of Science
- 4 years experience in QA in a pharmaceutical environment
- Previous management experience with product importation/distribution is an asset
- Knowledge of GMP & regulations as it relates to the importation and distribution of pharmaceutical products & medical devices
- Intermediate level knowledge of MS Word, Excel and Outlook
- Excellent analytical skills and above average attention to detail
- Excellent time management and prioritization skills
Address: 100Vaughan Valley Blvd, Vaughan
Shift: Monday – Friday 9:00am - 5:30pm
ACCURISTIX INC believes in a diverse and accommodating workplace. Accuristix Inc encourages and promotes applications from all qualified individuals, regardless of gender, age, race, ethnicity, disability or otherwise. ACCURISTIX INC is committed to providing full accommodation for persons with disabilities in all active processes and procedures including but not limited to the recruitment process. To request any accommodation, you may require to participate in the recruitment process (including alternative formats of materials or accessible meeting rooms) contact the main recruiting contact for the position to discuss your needs.
Job Type: Full-time
Flexible language requirement:
Ability to commute/relocate:
- Woodbridge, ON L4H 3C5: reliably commute or plan to relocate before starting work (required)
Application question(s):
- Do you have a Bachelor of Science degree?
Experience:
- QA in a pharmaceutical environment: 4 years (required)
- Consulting: 1 year (required)
- Regulatory QA Services: 1 year (required)
Work Location: In person
