Compliance Auditor

JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

Site Specific Information

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 audit s 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. 

Keys to Success:

Education:

Bachelor of Science (B.Sc.) in Chemistry, Biology, Pharmacy, or other related field

Experience:

Minimum 3 years of Good Manufacturing Practices /G ood Lab Practices auditing experience in pharma/medical devices.

Experience with SAP (an asset) .  

Equivalency :

Equivalent combinations of education, training, and relevant work experience may be considered. 

Knowledge, Skills, and Abilities :

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 w ell and efficient ly with limited supervision. Demonstrated computer proficiency with Microsoft Office programs. Proficiency with the English Language.

Physical Requirements: 

Light physical effort and fatigue. Walks, sits or stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typically located in a comfortable indoor area .  There may be regular exposure to mild physical discomfort from factors such as dust, fumes or odours , temperature extremes, loud noise, strong drafts, or bright lights. Use of Personal Protective equipment may be required and may include any of the following: s afety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, and respirator on occasionally .

Excellent Benefits

• Medical, Dental, & Vision benefits-effective Day 1

• Paid Time Off & Designated Paid Holidays

• Retirement Savings Plan

• Tuition Reimbursement

OTHER

• Relocation assistance is NOT provided.

• Must be legally authorized to work in Canada now or in the future, without sponsorship.

• Must be able to pass a comprehensive background check.

Compensation

The estimated annualized pay range for this position in Ontario is $69,400.00–$104,050.00.