Key role specific requirements:
- 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.
- Flexibility to work different shifts and on weekends.
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
Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a century’s experience in providing science-driven solutions to optimise the health, wellbeing and productivity of the world’s animals.
Bimeda’s global innovation programme sees six state-of-the art R&D centres across four continents collaborate on an enviable product development pipeline which anticipates the ever-evolving needs of the animal health industry.
Bimeda’s nine manufacturing facilities across seven countries allow the company to manufacture a broad range of preventative, curative and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water-soluble powders, pastes and non-sterile liquids.
Globally, the company focuses on the development, manufacture and commercialisation of quality Bimeda-branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry.
More Info at www.bimedacareers.com
Same Description for Internal and External