Sign up with

Already have an account? Log in here

Need some help?
Talk to us at +91 7670800001

Quality Assurance Coordinator at Hamilton Health Sciences

Hamilton, Ontario, Canada -

Full Time

Start Date

Immediate

Expiry Date

01 Jan, 26

Salary

0.0

Posted On

03 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Regulatory Training, Clinical Studies, Computer Systems Validation, Internal Audits, External Audits, Regulatory Inspections, Validation Documents, PHRI Quality Documents, CAPA Implementation, Communication Skills, Microsoft Office, Organizational Skills, Canadian Regulations, US Regulations, EU Regulations

Industry

Hospitals and Health Care

Description

Responsibilities include working closely with study teams in Hamilton to ensure quality conduct of our international studies; providing regulatory training in International and National regulatory requirements related to clinical studies (e.g. ICH GCP, FDA, EMA, 21 CFR part 11, etc.) and notifying staff and management on changes to regulatory requirements. Specific knowledge and expertise is required for Computer systems validation. In addition this position may participate in the conduct of internal process audits; support the QA team in the coordination of external audits/regulatory inspections; review validation documents to ensure they meet regulatory requirements and industry standards; prepare and maintain records and metrics related to management of PHRI Quality Documents and CAPA implementation. 1. A health related degree or equivalent 2. Previous experience in clinical quality assurance or coordination of clinical trials/research 3. Excellent communication skills, both oral and written 4. Excellent computer skills in all Microsoft Office applications 5. Position ideally suited to a well-organized individual 6. Sound knowledge of Canadian, US, and EU regulations relevant to the conduct of clinical trials 7. Ability to prioritize among competing responsibilities and meet expected timelines. 8. Previous involvement in sponsor audits of regulatory inspections preferred

Responsibilities

The Quality Assurance Coordinator will work closely with study teams to ensure the quality conduct of international studies and provide regulatory training. The role includes participating in internal audits, supporting external audits, and reviewing validation documents.