Quality Assurance Specialist

2 weeks ago

Markham, Ontario, Canada SGS Full time
Job Title: Quality Assurance Specialist

SGS is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality team, you will be responsible for ensuring that our clients receive high-quality services that meet their needs and expectations.

Key Responsibilities:
  • Review and approve CCRs and manage SOP review and approval process
  • Responsible for timely completion of the SOP reviews
  • Setup and ensure timely completion of the employee trainings
  • Be Trainings and Document control site representative and manage all the activities for these implemented programs
  • Maintain client test methods and specification data bases
  • Perform internal audits and follow ups for effectiveness
  • Maintain vendor evaluation program
  • Coordinate with clients and legal for quality agreements, maintain the data base and records
  • Participates in the regulatory and client audits
  • Work as a backup in some designated areas in the absence of QA management
  • Overlooks as a QA, the equipment qualification, calibration and maintenance program; overview the technical SOPs for completeness
  • Approve method/specifications assessment form if provided. Review all CCR/ technical memo of methods/protocols and reports
  • Work on special projects as assigned by the Management
  • Be backup for QA Associate
  • Be active back up for review and approval of all OOS and deviation investigations
  • Review and approve stability protocols, reports and CCRs
  • Review and approve equipment related protocols, and reports
Qualifications:
  • A minimum of a BSc degree (or equivalent) is required
  • Over three years of related experience
  • Previous experience in a Quality Assurance related role would be preferred
  • Must be capable to notice any GMP deficiencies in reports and protocols
  • Candidates must be proficient in using various type of computer software (Word, Excel, Outlook etc.)

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