About PharmEng Technology:
PharmEng Technology is a full service consulting firm that serves the pharmaceutical, medical devices and biotechnology industries in North America and internationally. Since 1997, the company has provided industry recognized consulting services assisting clients in the rapid commercialization of new product from drug discovery, strategic planning to process scale up.
PharmEng Technology has offices in various locations including Canada, America and Asia. We’ve got projects across Canada, USA, Europe and Asia.
Expertise we’re looking for (5+ years experience in the following areas):
- Quality Assurance
- General Validation
Role and Responsibilities:
As a consultant, review and assess project’s requirements/associated risks and develop appropriate work plan. Prepare SOPs, URS, FRS and other related validation documents and reports. Develop and execute validation documents and reports. Develop and execute validation protocols (IQ/OQ/PQ).
Provide regular project progress reports to PharmEng and the client. Communicate effectively within PharmEng and with clients, both verbally and written. Solve problems during validation process and address/advise on issues such as deficiencies, deviations and change control etc.
Complete assigned projects and tasks within agreed deadlines. Other duties as required.
Requirements of successful candidates:
Fluent in Japanese required. Minimum Bachelor of Science in relevant field. At least 5 years experience in validation, engineering and/or quality assurance in the Pharmaceutical and Biotech industry. Working knowledge of regulations(cGMP-FDA 21CFR 210/211, 600 and/or part 11, Health Canada GMPs, GAMP, and other related regulations ie. GLP, GCP, ISO etc).
Strong working knowledge of Microsoft Office applications. Excellent communication skills both written and oral, organizational and technical skills with problem solving ability. Management of assigned tasks and projects with minimal supervision.
Willingness to travel, Hold a valid driving license and passport, Must be able to legally work in Canada, USA, and Japan.
If you know of anyone who may be suitable for the roles mentioned, please refer them to the career section on our website.