Quality & Compliance Specialist, Kirkland (Qc)

6 months ago

Kirkland, Canada Valeo Pharma Inc. Full time

***

Contribute to establishing and maintaining high quality and compliance status of all products handled by Valeo Pharma Inc.to meet all Canadian cGMP regulations.

Ensure Quality compliance of internal/client audits, supplier qualifications, SOP’s document control, Change Control, CAPA Closure /Effectiveness, APQR, Quality Metrics for cGMP compliance in line with US FDA, Health Canada requirements.

**KEY RESPONSIBILITIES AND DUTIES FOR THIS JOB**
- Perform and follow daily, weekly, and monthly compliance activities with regards to deviation, complaints, change control and CAPA with internal and external partners.
- Provide QA expertise to internal partners (mainly Operations, Information Technology) and external partners (manufacturers, wholesalers, external warehouse, etc.).
- Collect, review, and approve all required documentation necessary for product release, including batch documentation review.
- Process product quality complaints of marketed products including complaint sample management. Issue reports and reply to customers.
- Participate in deviation investigations through deep root cause analysis (5-whys, fish bone, etc.) and help establish corrective/preventive actions.
- Perform internal inspections/self-assessments and participate in regulatory inspections.
- Perform supplier audits.
- Train personnel on regulatory requirements and standard operating procedures
- Review Annual Product Quality Review (APQR) and Stability Data from product manufacturers and document internal APQR.
- Track, request, and compile documentation for the compliance status of all foreign sites, to allow the importation of products in Canada via valid Establishment License
- Maintain specifications and methods up to date.
- Assess Change Requests, Deviations, Investigations and CAPAs.
- Act as AQPIC (Alternative Qualified Person in Charge) for Controlled Substances
- Perform all related activities for Control drug substances: renewal and modification of Narcotic license, importation/exportation permits, inventories, management of the Narcotics, procedures, Health Canada annual report for Controlled drug substances, Health Canada audits, and management of destruction.
- Other QA duties as assigned.

**KEY REQUIREMENTS FOR THIS JOB**

**EDUCATION**:

- B.Sc. in Chemistry, Biology or related sciences

**EXPERIENCE**:

- 5 to 7 years experience in the pharmaceutical industry with quality assurance experience, experience in regulatory affairs is an asset

**SPECIFIC SKILLS**
- Knowledge of cGMPs and Health Canada regulations regarding drugs and natural health products
- Strong Verbal and Written Communication Skills
- Problem Solving Skills
- Attention to Details
- Strong understanding of Good Documentation Practices
- Strong organizational skills
- Strong investigation skills
- High work pace
- Analytical skills
- Self-motivated/directed
- Ability to multitask in a highly stressful environment
- Ability to operate in a constantly changing environment
- Computer literate-proficient in use of word processors. Must be able to understand and utilize complaint database software and reporting tools.
- Project and Time Management Skills
- Interpersonal skills-must be proactive, personable, flexible, team-oriented
- Customer Service Skills

**LANGUAGES**
- French - Excellent knowledge
- English - Reading, writing and oral: Intermediate to advanced level

**COMPUTER KNOWLEDGE**
- SAP, MS Office, Adobe

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