Clinical Quality Assurance Coordinator

Our client, headquartered pharmaceutical company in Spain which is working at a complete international level is looking for a Clinical Quality Assurance Coordinator to ensure clinical trials (phase I-IV) compliance. 

Job Description 
  Our client, headquartered pharmaceutical company in Spain which is working at a complete international level is lookikng for a Clinical Quality Assurance Coordinator to ensure clinical trials (phase I-IV) compliance.

Responsibilities:

Plays a leadership role in maintaining the company's Clinical Quality Assurance (CQA) group focused on Good Clinical Practice (GCP) compliance
Will support internal and external Good Clinical Practice (GCP) audits to ensure that clinical trials are conducted in compliance with applicable regulations, ICH guidelines, Company procedures and protocols
Responsibilities will also include providing guidance to clinical study teams, training of staff, and development/maintenance of GCP or GVP related quality systems.
Maintains GCP quality systems
Independently initiates and manages the review and approval of SOPs in compliance with applicable regulatory requirements, and supports department infrastructure development
Leads the development of GCP audit plans to international sites and vendors
Ensures all audit-related corrective and preventive actions are followed up through completion
Provides expert GCP QA advice to cross-functional areas supported

Profile 

Minimum BS/BA degree in biological sciences, chemistry, or related field
3-4 years of progressive pharmaceutical experience in a clinical development area and related to QA activities
Minimum exposure of regulatory authority inspections and inspection readiness preferred
Excellent working knowledge and understanding of GCP-related requirements and proficiency of regulatory and ICH guidelines.
Excellent verbal and written communication skills,
Ability to work well in teams and independently
Ability to prioritize work, manage multiple projects while maintaining quality and advocate for compliance
Highly diplomatic and tactful individual with exceptional critical reasoning skills who is detail oriented

Contact Information 

 

 

Important 

Previous monitoring experience CRA I-II is a must 

Travelling availability (40-60%) worldwide is required our client is currently running phase I and phase III trials Europe and EUA. 

Application form : Clinical Quality Assurance Coordinator

Files must be less than 3 MB.
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Files must be less than 3 MB.
Allowed file types: txt rtf html pdf doc docx odt.
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