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Quality Manager
2 months ago
Resolute Workforce Solutions | Full time
- Work Experience Intermediate (5 to 8 years)
- City Toronto
- Country Canada
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 Quality Manager in Toronto, ON.
This is an on-site position.
Responsibilities
- Support the Operational Management Team in ensuring timely review, follow-up, closure and approval of various documents, such as: master and executed batch records, operational log books, sterilization and depyrogenation records, SOP, SWI, deviation, protocols, reports, work orders, worksheets, maintenance task lists, that are within the scope.
- Process failure investigations/deviations, batch recommendations and provide supporting reports.
- Coordinate investigations, Change Control Requests (CCR’s) and CAPA's and ensure minimal impact on product release.
- Perform audits in conjunction with Internal Auditor and Vendor Auditor to ensure compliance with cGMP standards, site and corporate policies.
- Develop tools for performance monitoring and provide feedback to the departments supported both formally (departmental presentations) and informally (shop floor review) and obtain agreement on corrective actions as required.
- Bachelor's Degree/Undergraduate Degree in engineering or technical discipline. Master's Degree preferred.
- Required 3 - 6+ years experience in pharma quality activities.
- Must be detail oriented as this position will be responsible for and review batch records.
- Experience in the pharmaceutical/bio pharmaceutical industry.
- Strong working knowledge of Quality System Regulations.
- Experience leading CAPA (Corrective and Preventive Action) activities.
- Life Insurance
- Long Term Disability
- Dental and Healthcare
Click the “I’m interested” button below, or
E-mail your resume in MSWord or pdf format to recruitment@resolutewfs.com with the following details in the e-mail's Subject Line: Quality Manager: 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.
We welcome and encourage applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process.
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