| Ref | USOT30793 |
| Company Description | Our client is a leader in outsourced laboratory services to pharma, biotech, medical device & cosmetic industries. Services to include: drug discovery for Phase I to IV clinical trials, biostatistical management, regulatory affairs, bioanalytical, quality testing in microbiology, analytical chemistry, biocompatitability, microbiology, sterility, method development and stability testing.
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| Job Description | Reporting to the Laboratory Manager, you will be responsible for the administration of the site Quality Management System of the laboratory in conjunction with programs and standards set up by the Life Sciences department. This position will also optimize and oversee laboratory Quality Systems in compliance with cGMP and GLP regulations. You will:
Monitor and maintain quality system in compliance with cGMP and GLP regulations.
Host regulatory agency and customer compliance audits of the laboratory.
Respond to regulatory and customer audits observations with corrective and preventive actions drawn from a thorough root cause analysis - within agreed upon time lines.
Fulfill all QAU responsibilities as defined by GLP and GMP regulations.
Conduct internal audits of all major systems of laboratory operation.
Supervise activities of raw data reviewers and scheduling and conduct of all equipment qualification and calibration.
Conduct annual cGMP and GLP training.
Assist other Managers/Supervisors in response to customer quality complaints and claims and works closely with the lab personnel to continuously improve lab products and services
Maintain appropriate laboratory accreditations, appropriate documentation control (electronically and hardcopy).
Corrective and preventive action program to ensure continuous improvement.
Maybe assigned and coordinate special or ad hoc projects as needed. |
| Skill Required | University degree in Biology, Biochemistry, Chemistry or a related science degree
A minimum of 5 years of proven technical Quality Assurance experience and knowledge in analytical laboratory operations and services.
2 - 3 years of experience in Quality Management Systems (preferably to ISO 17025 standard).
Superior organizational, communication and interpersonal skills are essential
Accountable, self motivated; provide team leadership and motivation towards a common goal.
Must be creative, innovative and task orientated and able to coordinate and motivate a team towards a common goal, able to work with technical, sales and management staff, ability to work well with others & independently, works well under pressure with proven time management skills and a strong attention to detail.
Innovative with a systematic approach for problem solving and proven ability to manage and coordinate multiple projects in a fast-paced, highly professional environment.
Proven ability to manage and coordinate multiple projects in a fast-paced, highly professional environment.
Demonstrates excellent verbal and written communication skills including grammar and composition.
Proficient in using various types of computer software (Word, Excel. PowerPoint, Outlook
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| Benefits | Competitive |
| Country | Canada |
| City, region | |
| Discipline | Other |
| Sector | Other |
| CV Email | Application by email |
