Quality urance Specialist
Quality urance Specialist
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Job Description
TFS HealthScience a global midsize Contract Research Organization (CRO) partners with biotechnology and pharmaceutical companies to ensure the quality and success of clinical development programs. We provide fullservice capabilities resourcing and Functional Service (FSP) solutions tailored to meet the needs of our clients.
About the Role:
As a Quality Assurance Specialist you will be fully dedicated to supporting a single sponsor providing specialized expertise in ensuring the quality and compliance of their product development and supply operations. In this role you will be responsible for overseeing qualityrelated activities and ensuring that regulatory requirements and quality standards are consistently met.
Key Responsibilities:
- Act as the primary quality contact for the sponsor addressing quality events such as complaints deviations and investigations. Lead root cause analyses and implement corrective and preventive actions.
- Manage change control processes ensuring that any modifications align with quality and regulatory standards.
- Review and approve quality documentation ensuring all product development and manufacturing processes meet the required standards.
- Oversee external partners and suppliers ensuring their operations comply with the sponsors quality systems and regulatory guidelines.
- Support the sponsor in maintaining and optimizing their internal quality processes contributing to continuous improvement projects.
- Assist with audits and inspections by preparing necessary documentation and ensuring full compliance with regulatory requirements.
Qualifications:
- A degree in a relevant scientific or technical field.
- Experience in quality assurance quality management or related fields particularly in product development or manufacturing.
- Strong understanding of quality regulations and standards within a regulated environment.
- Proven ability to manage quality events and ensure compliance with regulatory requirements.
- Strong communication and collaboration skills with the ability to work effectively with both internal teams and external stakeholders.
- Attention to detail proactive mindset and ability to manage multiple priorities.
What We Offer:This is a unique opportunity to work directly with a key sponsor contributing to impactful projects in a dynamic and collaborative environment. We offer a competitive salary comprehensive benefits and opportunities for growth within our organization.
About Us:TFS HealthScience is a global Contract Research Organization with years of experience partnering with companies to provide tailored solutions in clinical research and product development. We are guided by our core values of trust quality passion and flexibility which drive our commitment to delivering excellence in every project.
Be a part of a team that is making a difference in global healthcare!
Employment Type
Full Time
