Amador Bioscience (AmadorBio) is a global provider (CN, US, EU) of integrated clinical development services. As a leading partner for biotherapeutics R&D success, we drive the development of new drugs by providing the complete chain of clinical development services, aligned to the strictest international standards.
Our Belgium site currently offers pharmacometrics services, which we are now expanding to clinical research and later also bioanalytical services. We are looking for a Quality Assurance Coordinator (QA) with GCP / GCLP experience.
In this role, you will have a GLP QA function at a bioanalytical facility in Hasselt, Belgium. In this capacity, you will oversee all local aspects of functional operation and are accountable for maintaining client and regulatory satisfaction with all aspects of GLP compliance at the facility.
Our Belgium site currently offers pharmacometrics services, which we are now expanding to clinical research and later also bioanalytical services. We are looking for a Quality Assurance Coordinator (QA) with GCP / GCLP experience.
In this role, you will have a GLP QA function at a bioanalytical facility in Hasselt, Belgium. In this capacity, you will oversee all local aspects of functional operation and are accountable for maintaining client and regulatory satisfaction with all aspects of GLP compliance at the facility.
Quality Assurance Coordinator
Job description
This is what we want you to do at Amador Bioscience:
- Ensures recruitment, training, coaching, development and management of a competent GLP QA workforce to meet business site needs
- Plans and executes the necessary QA inspection programs to maintain local GLP compliance
- Ensures the consistent implementation, use and review of SOPs
- Negotiates with functional and operational internal stakeholders to improve quality and increase efficiencies
- Analyzes and interprets data in order to lead functional process improvement initiatives to drive efficiencies and effectiveness of Regulatory Compliance & Quality Assurance (RC&QA) processes
- Supports functional process improvement initiatives to drive efficiencies and effectiveness of business processes.
- Leads and effectively manages constructive crucial interactions with clients or regulatory agencies
- Interprets applicable quality regulations/standards and create appropriate policies and procedures
- Ensures Regulatory Compliance and Quality Assurance (RC&QA) management responsibilities, as indicated in applicable controlled documents, are followed
- Collaborate with the US and China QA team
Profile
- A minimum of a Bachelor’s Degree in a Biomedical, Chemistry, Biology, or biotechnology related discipline
- Experience may be substituted for education
- A minimum of 3 years of GLP / QA experience
Offer
- Remote work
- Combine remote work (3/5) with an office based job (2/5), you have a flexible schedule
- Extensive benefits package
Calculate your travel time
To : Amador Bioscience | Kempische Steenweg 309, 3500 Hasselt
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