As a Quality Assurance Consultant, you will work with our clients on the following missions:
- Responsible for maintaining and improving the QMS and ISO 9001 Certification.
- Schedules, plans reviews and analyzes internal quality system audits.
- Ensures effectiveness of Corrective and Prevention Action (CAPA) Program
- Drives the development and control of user friendly process documents.
- Ensures process and product Changes are documented and customer notification is performed.
- Manage deviations, anomalies, Customer complaints, CAPA, change control …
- Define the quality indicators
- Process validation (special or manufacturing)
- Write review and manage the Quality documentation (procedures, protocols, operating modes)
- Participate in pre-audits, audits and preparation for inspections
- Setting up and updating the QMS
Bachelor’s Degree in Science or Business required. Master’s Degree preferred
- A minimum of five (5) years of Operations, Engineering or QMS experience required
- Experience with ISO 9001, ISO 13485 or cGMP required
- Effectively resolves conflict, works in teams, and meet deadlines is required
- Proficiency with Word, Excel, and PowerPoint required
- Excellent writing, verbal communication, and presentation skills are require
Must have demonstrated understanding of cGMP. Strong understanding of QA principles, industry practices, and standards with demonstrated ability to apply these to GMP is required.