Septa Pharmaceuticals Inc., is proudly a Canadian owned and operated Generic Pharmaceutical Company based in Mississauga, Ontario. Our Mission is to provide quality generic pharmaceuticals and healthcare products to advance and nourish the quality of life in domestic and global markets.
We are excited to announce the opening for the position of Manager –Quality Assurance. Working to support operations and to ensure compliance as related to pharmaceutical products and regulations, the incumbent will principally be responsible for managing all QA responsibilities as well as oversee the drafting and implementation of Standard Operating Procedures (SOPs) related to Operations.
- Abide by the laws and by-laws of the company and the country of operations acting as a role model setting corporate standards and expectations both, internally and externally.
- Engage in the process of drafting, reviewing, and implementing SOPs for the Company’s Operations department.
- Develop and conduct internal audits pertaining to company operations, presenting findings to the senior management.
- Participate in any HPFBI inspections/audits, serving as a subject matter expert for any inquiries that arise during the inspection/audit, including the drafting of action plans (if required).
- Monitor and perform GMP inspections to assess compliance with Division 2 of HPFBI with Operations.
- Handle all product lot release activities, including the review of manufacturing and other documentation to support batch releases.
- Work with Operations team to create necessary operational documents and transition daily support activities with team.
- Proactively research, analyse and recommend updates and improvements to existing systems and/or SOPs.
- Other duties, as assigned.
- 6-7 years of experience in a related quality position with experience in Canadian Drug GMP.
- Minimum B.Sc. from an accredited Canadian University (preference will be given to majors in Chemistry and/or Microbiology).
- Solid knowledge base in GMP, Establishment Licensing, NHM GMP requirements and other activities related to Canadian Drug products.
- Experience in reviewing master product documents and auditor training, including conducting third party audits.
- Excellent written and oral communication skills.
- Proficient in Microsoft Word, Outlook, and Excel.
Primary Location Canada-Ontario-Greater Toronto Area
Job Term N/A