Our client is a leading pharmaceutical company that specializes in dermatological treatments with a mission to advance dermatology through innovation and manufacturing. They are looking for a Senior Quality Assurance Specialist in the GTA.
The successful candidate would be a member of the Quality Assurance department, and report to the Senior Manager, Quality Assurance. This position would require 5-10% of travel to support audit activities.
- Responsible to ensure that imported and distributed products by the Company meet the expectations and requirements of global and local policies and Health Canada regulations.
- Must have thorough knowledge of Health Canada (TPD) guidelines and GMPs, as well as the Food & Drug Act/Regulations.
- The Senior Quality Assurance Specialist works independently and provide direction to other QA team member to assist with all aspect of (cGMPs) including batch record review, batch disposition, new product introduction and supplier/ vendor management.
- Quality oversight responsibilities include ensuring adherence to SOPs and requirements, proper change control, corrective action and preventive action plans (CAPA) management, assessments for changes to processes, risk management, ensuring documentation and investigations meet all requirements.
- Bachelor’s Degree (Engineering or Sciences)
- Additional graduate certificate in pharmaceutical field
- 5 to 7 years of related experience in Quality Assurance within a pharmaceutical and Medical Device industries
- 2+ years’ experience with emphasis in Importation and Distribution of pharmaceuticals, Medical Device and NHP products.
- Understanding of pharmaceutical manufacturing and laboratory processes.
- In depth knowledge of applicable Health Canada and global pharmaceutical regulations (e.g. ICH)
- Experience auditing preferably with an auditing certification
- Basic MS Office computer and software proficiency
To apply, please submit your resume using the Apply Now button.
We thank all interested applicants, however, only the candidates chosen for an interview will be contacted.