Quality Assurance System Specialist
il y a 4 semaines
Quality Assurance System Specialist
Flash Therapeutics is seeking a dedicated and enthusiastic Quality Assurance System Specialist to become a vital part of our innovative team. In this role, you will ensure that our quality management system adheres to all regulatory standards while preparing the organization for GMP (Good Manufacturing Practices) inspections. Additionally, you will be instrumental in overseeing the quality assurance processes related to our suppliers and subcontractors.
Key Responsibilities:
1. Management of Quality Systems:
- Develop and enhance the quality management system on an ongoing basis.
- Draft, update, and validate quality documentation.
- Oversee deviation management, CAPA (Corrective and Preventive Actions), change control, and customer feedback processes.
- Establish and monitor internal audit schedules.
- Ensure the quality assurance of computerized systems in collaboration with both external partners and internal stakeholders.
- Track and analyze performance indicators within the sector.
2. Readiness for Inspections:
- Organize and manage activities related to client inspections and audits.
- Maintain a state of inspection readiness at all times.
- Provide continuous training for staff on GMP standards and internal quality protocols.
3. Quality Assurance for Suppliers and Subcontractors:
- Assess and qualify suppliers and subcontractors in accordance with GMP standards.
- Perform quality audits on suppliers and subcontractors to verify compliance with GMP regulations.
- Manage the follow-up of subcontracted analyses, including contracts, timelines, and results management.
Ideal Candidate Profile:
- A Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Biotechnology, or a related discipline.
- At least 3 years of experience in a comparable position within a GMP-regulated setting.
- Comprehensive understanding of GMP regulations.
- Strong communication and problem-solving abilities.
- Capability to work autonomously as well as collaboratively within a team.
- Proficiency in professional English.
- We value a candidate who possesses not only technical expertise but also a positive attitude and the ability to thrive in a dynamic environment.
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