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Senior Qc Manager Jobs
Company | BioSpace |
Address | Mississauga, Ontario, Canada |
Employment type | FULL_TIME |
Salary | |
Category | Internet News |
Expires | 2023-08-15 |
Posted at | 9 months ago |
RESILIENCE is creating the first sustainable ecosystem for advanced biopharmaceutical manufacturing. We’re building a robust, dynamic, and diverse network of manufacturing capability and talent – investing in innovation every step of the way.
- Review and approve CoAs for batch release.
- Ensure staff record and report according to established procedures any deviations from company procedures, or other discrepancies that may affect or indicate a problem with product quality; determine and implement any immediate corrective action as necessary; ensure the development of long-term corrective action including identifying root causes; facilitate, review and approve final implementation of corrective action plans.
- Manage the assigned projects by closely working with project managers completing the related tasks in a timely manner.
- Ensure implementation and execution of laboratory control programs including documentation control, sample/reagent control, reserve/stability samples, LIR and out of specification investigations.
- Oversee the execution of test method development and optimization.
- Ensure accurate and timely completion and approval of Quality Control laboratory testing and records.
- Ensure that the laboratory facilities and operations follow Safety and Environmental regulations, including chemical handling and disposal of laboratory waste.
- Implement programs to assure continuous improvement of procedures and processes (test methods and system SOPs).
- Ensure that project plans are created according to QC capacity to ensure timely execution and completion of test method transfers and qualifications/validations.
- Ensure all departmental staff is trained to perform duties prior to performing a function
- Implement robust programs to ensure that applicable equipment and analytical instruments are qualified, maintained, and calibrated, and that system suitability is properly verified. Review and approve QC equipment IQ/OQ/PQ protocols and reports.
- Perform any other job-related duties as assigned
- Oversee the creation, approval, training and implementation of QC test methods and training modules.
- Report Health and Safety incidents, accidents, or potential hazards.
- Ensure the execution of stability studies to meet client requirements and ICH guidelines.
- Willingness to work overtime or weekends as needed to meet business needs
- Knowledge of ICH guidelines regarding transfer and validation of analytical methods, as well as stability program
- Significant QC experience in Pharmaceutical / Biopharmaceutical industry
- Working knowledge of FDA, Health Canada, and EU GMPs
- BSc. in chemistry or a related science
- Demonstrated leadership and management skills
- Experience managing small to mid-sized teams
- Client management experience will be considered an asset
- Be self-motivated, highly organized, and able to work in the fast-paced environment
- Experience leading investigations and performance improvement projects
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