Audit Auditor

5 days ago

Markham, Canada Sentrex Health Solutions Inc. Full time

Job Category: Quality and Pharmacovigilance

Requisition Number: QAAUD002095

Posted: November 22, 2024

Employment Type: Full-Time

Locations

Showing 1 location

Description

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 schedule, conduct, and document assigned audits (both internal and external) as well as participate in regulatory inspections in compliance with approved procedures and schedules. You will also be an ambassador for the quality culture at Sentrex.

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

  • Maintain the approved vendor list, vendor audit schedule, and self-inspection schedule.
  • Perform risk ranking on suppliers based on products or services provided, on-site audit history, and deviation trends.
  • Schedule and perform audits of vendors and internal self-inspections as per the audit schedule.
  • Generate and communicate supplier key performance indicators (KPIs) where applicable.
  • Write and communicate audit reports, close-out letters in accordance with company formats and timelines ensuring clear communication of audit findings to the relevant project team members.
  • Review CAPAs for audit observations from vendors and internal stakeholders and provide guidance on applicable regulations.
  • Follow up with suppliers and internal stakeholders to ensure timely closure of audit observations.
  • Write and review SOPs, supplier or service agreements, and wholesale quality agreements.
  • Participate in hosting client and regulatory audits.
  • Maintain accurate and timely documentation of all auditing activities.
  • Perform additional duties as determined by your Manager.

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

  • Bachelor’s degree in Chemistry, Biochemistry, Biology, or other related discipline.
  • A minimum of three (3) to five (5) years of knowledge and working experience with all aspects of quality assurance related to a pharmaceutical organization.
  • Well organized and detail-oriented.
  • Thorough knowledge and understanding of Canadian (Health Canada) Food and Drug Regulations and guidelines.
  • Experience with GMP, GVP, GCP, ICH regulations and guidelines.
  • Experience with auditing software vendors and/or GAMP V / CSV is an asset.
  • 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:

  • Commitment to providing a high level of service to internal and external clients.
  • Highly adaptable with a track record of success during times of growth and organizational change.
  • Proven track record of developing trust and influence at multiple levels.
  • Impactful and candid communication style.
  • Exceptional organizational skills with the ability to build effective working relationships with colleagues, management, and stakeholders.

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 Days.
  • Competitive Benefits Package including Dental & Extended Health Benefits, AD&D, LTD & Employee/Dependent Life Insurance.
  • Employee & Family Assistance Program.

Sentrex Health Solutions is proud to be an equal opportunity employer demonstrated by our commitment to diversity, inclusion, belonging, equity, and accessibility. We provide a safe space for all team members to express their individuality within our corporate culture.

We encourage you to apply and accept all applications. We realize that not every candidate will meet every single desired qualification. If your experience looks a little different from what we have identified and you think you can bring value to the role, we would love to learn more about you

Accommodations can be made available upon request for those candidates taking part in the selection process.

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