Quality Specialist

Act as a critical technical resource for our plant expansion program. The Quality Specialist is responsible for ensuring the quality assurance and/or quality control systems for new filling and packaging equipment meet all quality standards.

Responsibilities

- Developing documentation as required by the project: SOPs, protocols, reports, etc.
- Completing critical assessments of data and documents to identify gaps compared to regulatory requirements
- Perform review of critical project documentation including validation protocols, standard operating procedures, user requirements, design reviews and providing GMP guidance to research and development.
- Review and approve quality documents including but not limited to sampling analysis and labelling forms, deviations/amendments (planned deviations), OOS/OOT/OOC investigations, logbooks, cleaning records and temperature monitoring data

Qualifications

- Bachelor of Science degree or equivalent. Microbiology strongly preferred.
- 2-5 years’ experience in QA in pharma
- An understanding of (cGMP) manufacturing with prior QA and/or laboratory experience being a definite asset
- Demonstrated ability to deliver on commitments
- A proficiency for multi-tasking and ability to juggle multiple tasks
- Excellent time management and project management skills

Application Process

Application process: Please send your resume using the form below.