Responsibilities include but are not limited to:
- Assesses potential impact of incidents and deviations on the quality and suitability of the product for sale. Includes conducting in-process batch record review and determining batch status, e.g. release, reject or product hold for further clarification or investigation.
- Performs internal QA audits on manufacturing lines and finished products to ensure that they are compliant with corporate policies, practices, and procedures.
- Provides oversight and QA approval to various systems (CAPA, Deviation) through which quality history and trending are monitored and corrective/preventative actions or quality improvements are recommended, implemented and consistently managed.
- Investigates both individually and as a team member, deviations, and OOS results to determine product impact, root cause and corrective/preventative actions.
- Monitors QA systems and advises/presents to management team on system performance; publishing metrics/reports regarding performance against set goals.
- Provides support to other functions of Quality Assurance department which includes but not limited to the preparation of master documents and the coordination of documentation services through other departments.
- Promotes and advocates quality achievement and performance improvement across the organization.
- Participates as required in Health Canada, FDA & customer audits and ensures corrective actions are completed with customer specifications or SOPs.
- Ensures ongoing compliance with local, national, and international standards and legislation.
- Other duties as assigned.
- 2-3 years’ relevant experience in a regulated Pharmaceutical industry including Quality Assurance, Quality Control.
- BSc degree in science or related field, QA courses or training.
- Knowledge of pharmaceutical QA methodologies, cGMP, Quality Systems, Analytical Chemistry.
- High integrity, excellent attention to detail, analytical thinker, ability to organize and prioritize, and work in team environment, take initiative.
At Bimeda we are committed to fostering an inclusive, barrier-free and accessible environment. Part of this commitment includes arranging accommodations to ensure an equitable opportunity to participate in the recruitment and selection process. If you require an accommodation, we will work with you to meet your needs.
The job posting is available in an accessible format upon request by contacting the Human Resources Manager