The QC Manager will manage and coordinate all activities of the QC laboratory to ensure that all products are analyzed and released according to specifications and validated methods in compliance with current Good Manufacturing Principles (cGMP) regulations.
In more details, he or she:
- Actively participate and support analytical testing and release of products in order to ensure that products are within their approved specifications within the established timelines
- Write and put in place SOPs for establishing operational procedures of quality to assure conformity to regulations
- Provide technical support to Management and QC employees during trouble-shooting activities
- Coordinate the analysis of finished products, in-process and stability samples
- Coordinate and purchase all reagents, lab supplies etc.
- Prepare and manage the weekly schedule based on business priorities
- Optimize and organize the laboratory activities (personnel and equipment) to maintain operational efficiency
- Assure proper functioning of the lab
- Prepare investigations and deviations
- Participate in the annual preparation of annual reports for finished products
- Put in place procedures to ensure work environment safety
- Supervise personnel (4-6 analysts)
- Actively participate and contribute to the overall performance of safety committee, and assure active participation of subordinates. Enforce use, care and maintenance of personal protective equipment. Keep employees constantly informed of risks and unsafe conditions associated with manufacturing process, detect any violation, and take corrective actions as required.
- Develop and maintain effective working environment by promoting and enhancing self-esteem and the highest level of participation and integration in harmony with the company and people values.
- Education: Masters or Bachelor of Science in Chemistry
- Experience: Minimum 5 years
- Technical Knowledge: cGMPs and GLPs, instrumentation (HPLC, UPLC, Dissolution Bath, spectrophotometer, etc).
- Administrative/Managerial Competencies: computer literate, statistics, planning and organizing, critical thinking, leadership skills, performance management, goals and objective oriented
- Interpersonal Skills/Competencies: Tactful, reliable, persuasive, dependable, consistent, flexible, sensible, objective and emphatic.
- Other: Excellent oral and written communication skills in English and French.