QA Auditor

1 week ago

Markham, Canada Sentrex Distribution Inc. Full time

**Position Type**:Full Time

**Department**:Quality Assurance - General & Admin

**Work Location**: Canada

**Work Arrangement**: Hybrid

**Work Hours**:Monday to Friday 9am-5pm

A proudly Canadian company, Sentrex Health Solutions is a fully integrated specialty distributor and patient support provider for pharmaceutical manufacturers, physicians, and their patients. We provide innovative solutions focused on ensuring patients have access and the support they need to maximize their treatment outcomes. We do this through strategic distribution models and patient support programs that are backed by powerful, integrated technology and experienced, cross-functional teams. Our core capabilities include **Specialty Pharmacy Services, Customized Solutions for Warehouse, Wholesale & Distribution, Patient Support Programs, as well as HCP & Clinic Services.**

**Come and join our team But first, let us tell you why we love working here**:

- We are 100% Canadian with locations across the country
- State-of-the-art facilities to provide high-quality products and services
- The opportunity to be a part of a winning, high-performing team
- Collaborative, engaging workplace culture - **we are passionate about our people**
- Flexible working environment that promotes a healthy work-life balance
- Diverse and inclusive culture where your talent and commitment to excellence is welcomed and valued
- High-growth environment that provides opportunities for learning and growth supported by our Employee Development Program and industry-leading, in-house corporate training offered throughout the year
- Quarterly virtual social events

**The Opportunity**:
The QA Auditor role is based in our facility in Markham and the key functions include working with cross functional teams to ensure the Quality Management System (QMS) is being followed and supported by our vendors. In this role you will be schedule, conduct and document assigned audits (both internal and external) as well as participating in regulatory inspections in compliance with approved procedures and schedules. They will also be an ambassador for the quality culture in Sentrex.

**A Day in the Life (What you will do here)**:

- Maintaining the approved vendor list, vendor audit schedule and self-inspection schedule.
- Performing risk ranking on suppliers based on products or services provided, on-site audit history and deviation trends.
- Scheduling and performing audits of vendors and internal self-inspections as per the audit schedule.
- Generating and communicating supplier key performance indicators (KPIs) where applicable.
- Writing and communicating audit reports, close-out letters in accordance with company formats and timelines ensuring clear communication of audit findings to the relevant project team members.
- Reviewing CAPAs for audit observations from vendors and internal stakeholders and providing guidance on applicable regulations.
- Following up with suppliers and internal stakeholders to ensure timely closure of audit observations.
- Writing and reviewing SOPs, supplier or service agreements and wholesale quality agreements.
- Participating with hosting client and regulatory audits.
- Maintain accurate and timely documentation of compl auditing activities.
- Additional duties as determined by your Manager.

**What you need to ensure you are set up for success**:

- 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) Food and Drug Regulations and guidelines.
- You have experience with GMP, GVP, GCP, ICH regulations and guidelines.
- Experience with auditing software vendors and/or GAMP V / CSV is an asset.
- You have excellent verbal and written communication skills.
- Bilingualism (French/English) is considered an asset.
- Experience participating in regulatory agency inspections is an asset.
- Certification in a recognized quality auditor program is an asset

**What makes you a great fit for this team**:

- Your commitment to providing a high level of service to your internal and external clients.
- You are highly adaptable with a track record of success during times of growth and organizational change.
- You have a proven track record of developing trust and influence at multiple levels.
- You demonstrate an impactful and candid communication style.
- You have exceptional organizational skills with the ability to build effective working relationships with colleagues, management, and stakeholders.

***Why join Sentrex?**

We value our employees Our permanent full-time employees are provided with a:

- Competitive Salary and generous vacation entitlement
- Wellness Program (5 paid days off for your well-being)
- Paid Sick

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