Location
North York, ON | Canada
Job description
Job Information
Industry
Pharma
City
North York
State/Province
Ontario
Zip/Postal Code
L4B
Job Description
Resolute Workforce Solutions (Staff augmentation subsidiary of Brevitas Consulting Inc.) is dedicated to helping organizations achieve tangible results and lasting improvements via successful project delivery, continuous process improvement, and effective management of change. Our expertise is in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Project Management.
We are looking for a highly motivated and energetic professional to join our team as a QA Manager / Auditor in North York, ON
The QA Manager/ Auditor will support the management of: Quality Systems, Quality Third Parties, Self-inspections, and quality projects/initiatives that ensure all product development is in accordance to cGMP standards, and regulatory requirements.
Responsibilities:
- Responsible for maintenance of Quality Systems and compliance, including updating procedures (SOP’s/training material).
- Support the preparation of various reports (deviation trends, periodic access reviews)
- Manage third-party processes, in alignment with company’s Global requirements and regulations.
- Ensure appropriate quality oversight and performance evaluation (including SCNs, QSTPs, supplier deviations) of third-party suppliers, sub-contractors and service providers.
- Ensure quality agreements with third parties are developed and managed during their lifecycle.
- Perform external audits (as required) and self-inspections.
- Responsible for change management activities related to Quality Systems
- Identify opportunities for improvements to quality processes
- Update and share within R&D new rules and industry regulations, and align internal quality systems with best practices.
Qualifications:
- Bachelor of Science Degree in a relevant discipline (e.g. Biology, Microbiology, Biochemistry, Immunology, Chemistry, Biotechnology)
- 5+ years relevant quality experience in pharmaceutical industry.
- Strong technical background, expertise in vaccines or biologics with demonstrated knowledge of quality practices.
- Experience in quality third party management, audits, and manufacturing processes/R&D Labs are fundamental in performing the job.
- Written and communication skills are critical to ensure team members are guided through cGMP (Quality System) requirements.
- Excellent knowledge of the GMPs for US, Canada, and Europe.
To Apply:
- Click the “I’m interested” button below, or
- E-mail your resume in MSWord or pdf format to [email protected] the following details in the e-mail'sSubject Line: QA Manager/Auditor: FIRST NAME, LAST NAME.
We thank all applicants in advance; however, we will only contact the candidates whose qualifications match closely to the job requirements.
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