24 Oct
SGS
Markham
Job Description
- 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.).
30+ days ago