Compliance Auditor
About The Position
Our Whitby Site specializes in commercial manufacturing for a full range of conventional dosage forms with specialized capabilities, and houses a fully integrated pharmaceutical development services (PDS) facility. Discover Impactful work: To conduct internal, external and client Good Manufacturing Practices (GMP) audits. Day in the Life: Perform internal Good Manufacturing Practices audits of all departments as required and prepare written reports to document the findings. Participate in the site Fit and Finish Audit. Facilitate site preparations and execute audits for clients and regulatory inspections including regulatory awareness programs for each agency. Assist with ongoing guidance and training of auditors (if applicable). Assist with regulatory requests. Manage Audit Observations and Audit CAPAs Provide administrative support for ongoing Compliance projects. Maintain a safe working environment and report potential hazards.
Requirements
- Minimum 3 years of Good Manufacturing Practices /Good Lab Practices auditing experience in pharma/medical devices.
- Exceptional Good Manufacturing Practices, GLP, and HPBI/FDA compliance knowledge.
- Proficiency with the use of quality investigation tools – FMEA, Fishbone, etc.
- Familiarity with SFLMS.
- Familiarity with managing GMP regulatory requests.
- Detail-oriented and organized, with a high degree of accuracy and thoroughness.
- Excellent organizational skills and ability to prioritize in a fast-paced environment.
- Strong written and oral communication skills.
- Works well and efficiently with limited supervision.
- Demonstrated computer proficiency with Microsoft Office programs.
- Proficiency with the English Language.
- Must be legally authorized to work in Canada now or in the future, without sponsorship.
- Must be able to pass a comprehensive background check.
Nice To Haves
- Experience with SAP (an asset).
Responsibilities
- Perform internal Good Manufacturing Practices audits of all departments as required and prepare written reports to document the findings.
- Participate in the site Fit and Finish Audit.
- Facilitate site preparations and execute audits for clients and regulatory inspections including regulatory awareness programs for each agency.
- Assist with ongoing guidance and training of auditors (if applicable).
- Assist with regulatory requests.
- Manage Audit Observations and Audit CAPAs
- Provide administrative support for ongoing Compliance projects.
- Maintain a safe working environment and report potential hazards.
Benefits
- Medical, Dental, & Vision benefits-effective Day 1
- Paid Time Off & Designated Paid Holidays
- Retirement Savings Plan
- Tuition Reimbursement
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
