- In-process Quality Assurance which includes manufacturing, filling, on-floor visual inspection, and packaging.
- Handling Quality Management systems (Deviations, Change controls, Market complaints, Quality Risk Management & CAPA programs)
- Process Validation and Cleaning Validation
- Annual Product Review and Continues process verifications.
- Document creation, issuance, and control
- Create, review, and revise SOPs
- Batch records review and release program
- Assist with the document control for all GMP related activities
- Plan, estimate, specify and evolve the QA planning
- Verifying that raw materials or components involved in the production process are of suitable quality
- Assessing whether employees need training to prevent nonconformances during production/packaging
- Oversee all new hire GMP training requirements as well as monitoring and maintaining all GMP training records
- Some in process Quality Control testing
- Other duties as assigned by manager
- 0-3 years knowledge and working experience with all aspects of quality assurance, which relate to a pharmaceutical / medical device development organization.
- Bachelor’s degree in science, chemistry, or related field
- Ability to work independently and in a group on a variety of projects
- Ability to maintain a high degree of accuracy and attention to detail
- Ability to handle a fast-paced, multi-tasking environment, and prioritize effectively
- Planning, organization, and execution skills
- Strong problem-solving techniques and ability to make sound decisions
- A thorough knowledge and understanding of Canadian, US FDA and European regulations (GMP)
- Excellent verbal and written communication skills required
To be considered, please click "Apply Now."