Quality Assurance Professional
This role entails collaborating with management to oversee the implementation and maintenance of a robust Quality Management System.
You'll be responsible for ensuring all technical operations related to pharmaceutical manufacturing adhere to national and international regulations (GMP) and quality policies.
Take an active role in supporting operations by identifying, developing, and implementing quality enhancements in line with business needs, technical advancements, and regulatory standards.
Key Responsibilities:
* Ensure intermediates and active pharmaceutical products are produced and released in accordance with quality standards and applicable regulations.
* Follow up on product-related change control, failure investigation, deviations, qualification of equipment, cleaning validation, process validation, stabilities, CAPA, and action plans.
* Review batch records from intermediates to drug substance.
* Oversee batch disposition of chemical intermediates.
* Authorize technical transfers towards manufacturing.
* Support BTO Management in developing and implementing technically robust Process and Equipment Support Systems.
* Drive the identification of improvement opportunities and develop quality projects in response to business requirements, technical changes, identified risks, audit observations, and regulatory requirements.
Requirements:
* A master's degree in chemistry or biochemistry or a degree in pharmacy or chemical engineering.
* Minimum of 3 years in a regulated pharmaceutical environment or other life science field, including experience in Quality Assurance or Quality Control.
* Fluent in English and French.
* Experience with Quality Management System.
* Demonstrated ability to balance multiple priorities, provide leadership, and work with minimal supervision.