Pharmaceutical - Quality Assurance Specialist

3 weeks ago

Toronto, Canada Amaris Consulting Full time

**Who are we?**:
**Amaris Consulting** is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade - this is made possible by an international team of 6000 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

**Brief Call**: Our process typically begins with a brief virtual/phone conversation to get to know you The objective? Learn about you, understand your motivations, and make sure we have the right job for you

**Interviews** (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities

**Case study**: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.

We look forward to meeting you
**Job description**:
We are looking for dynamic consultants to grow our **Life Sciences **team in Toronto**.** Your experience, knowledge, and commitment will help us to face our client's challenges.

You will be supporting different projects through your expertise as a **Quality Assurance Specialist.**

**Your main responsibilities**:

- Document Control: Maintain and author SOPs, change controls, PQRs, deviations, and other GMP documents
- Support the preparation and execution of external and internal audits.
- Ensure a high degree of product quality through the implementation & education of QA policies
- Provide technical and GMP training support as required
- Support the development of Quality Systems in collaboration with on-site and global quality teams.

**Qualifications**:

- Bachelor's degree in chemistry, biochemistry, microbiology, pharmacy, or related discipline
- 4+ years of experience in a similar role in Quality Assurance in a pharmaceutical environment.
- Knowledge of Health Canada & FDA Regulations
- Strong knowledge of Good Manufacturing Practices (GMP).
- Strong understanding of quality management systems (QMS) including product release, document management, change control, investigation and CAPAs.
- Experience in equipment validation is considered an asset
- Demonstrated ability to work effectively in a team
- Excellent communication skills in English

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