Mid-level industry position
SGS Employee Sign up Type of employment: Regular Reporting to: QA Manager Location: Mississauga, ON
Main focus of this position is playing a Quality Assurance Unit role for GLP and GCP studies. The position is entirely separate from and independent of the personnel engaged in the direction and conduct of the study.
Make an impact with SGS!With more than 97,000 employees and 2,600 offices and laboratories across the world, SGS is a silent force working hard behind the scenes to deliver quality and integrity to businesses across nine industries. As the world’s leader in providing inspection, verification, testing and certification services, Forbes ranked the SGS Group as one of the world’s top multinationals and one of the world’s most innovative companies. The Dow Jones Sustainability Index has also recognized the SGS Group for its sustainability processes. In Canada, SGS employs over 2,000 team members across 70 locations.
- Perform training of personnel for completing of the GLP forms.
- Coordinate GLP activities of QAU verification with laboratory operations
- The QAU is responsible for monitoring each study to assure management that the facilities, equipment, personnel, methods, practices, records and controls are in conformance with the regulations applicable to the GLP studies.
- The GLP Master Schedule form will be reviewed quarterly by the QAU.
- The GLP Status form is updated each time a phase of the study is completed. The phase, date the phase was audited, and the name of the auditor are filled in.
- It is the responsibility of QAU to ensure the approved GLP study protocols and amendments are also maintained in the GLP files.
- Each periodic inspection performed by QAU, including any observations, is documented on the GLP Study Audit form. This form is completed to show the date of the inspection and any audit observations.
- The QAU determines if any deviations from approved protocols or SOPs were made without proper authorization and documentation. Deviations from the approved protocol, or other problems or discrepancies observed during the course of an inspection, are noted on the audit form and are brought to the attention of the Study Director and Management immediately.
- Education: Minimum BSc, in biological sciences
- Experience: over 5 years of GLP experience and knowledge of regulatory requirements 21CFR part 11 and OECD for GLP.
- GLP knowledge and practical experience
- Must be able to read, understand and follow work instructions in a safe, accurate and timely manner.
- Candidates must be proficient in using various types of computer software (Word, Excel. PowerPoint & Outlook).
- Proven ability to manage and coordinate multiple projects in a fast-paced, highly professional environment.
- Candidates must demonstrate excellent verbal and written communication skills including grammar and composition.
- Ability to work well with others & independently.
- Proven time management skills and a strong attention to detail.
- Works well under pressure.
SGS Canada is an equal opportunity employer and we are committed to achieving greater accessibility by providing accommodation for people with disabilities during our hiring process. Accommodations are available on request for qualified candidates during each stage of the recruitment process.
Please note that candidates applying for Canadian job openings should be authorized to work in Canada.