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Quality Compliance Auditor

3 months ago

Laval, Canada Prometic Full time

At Prometic, employees work at saving lives, one role at a time. Located at the heart of the Cité de la Biotech in Laval, Prometic is in full growth-mode now that we are commercializing a treatment recently approved by the FDA for orphan diseases affecting children. This treatment, made of plasma-derived proteins, will allow these children to have a new pathway to hope.

To contribute to this revolutionary and innovative project, we are looking for a Quality Compliance Auditor.

The **Quality Compliance Auditor **will contribute to the team’s success by:

- Performing external and corporate quality audits and maintaining the supplier qualification program.
- Maintaining the approved supplier list, performing risk ranking on suppliers based on accumulated data and on-site audits, and following up with suppliers regarding audit observations.
- Generating and communicating supplier key performance indicators (SKPS).
- Writing and communicating audit reports, close-out letters, SOPs, supplier quality agreements and corporate quality agreements.

**You are the right person for this role because**:

- You have a Bachelor’s degree in Chemistry, Biochemistry, Biology or other related discipline and a minimum of three (3) to five (5) years of knowledge and working experience with all aspects of quality assurance which relate to a pharmaceutical organization
- You are well organized and detail oriented.
- You have a thorough knowledge and understanding of Canadian (Health Canada), US-FDA and European regulations (EAM)
- You have experience with GMP, GLPs, GCPS, ICH regulations and guidelines
- You have excellent verbal and written communication skills in both French and English
- Experience participating in agency inspections is an asset
- Certification in a recognized quality auditor program is an asset
- Experience with blood regulation is an asset

**Prometic offers you**:

- A fantastic team who strives at doing things in the best possible way;
- A casual environment;
- A « start-up » culture that values autonomy, innovation and collaboration;
- A competitive salary and benefit package
- A unique opportunity to change lives through your commitment and contribution.

**Send us your resume right away**

**The usual fine lines**:
Prometic is an equal opportunity employer.

**Job Types**: Full-time, Permanent

**Benefits**:

- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Life insurance
- On-site parking
- Paid time off
- RRSP match
- Vision care

Schedule:

- Day shift
- Monday to Friday

Supplemental pay types:

- Bonus pay

Work Location: Hybrid remote in Laval, QC