Quality Assurance Officer of GCPs for Clinical Development
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Quality Assurance Officer of GCPs for Clinical Development
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Mission
Quality Assurance Officer of GCPs for Clinical Development has the responsibility for overseeing and ensuring compliance with Ferrer's internal procedures and GCP in all assigned areas of responsibility achieving continuous improvement initiatives into the Quality System.
Mission
Quality Assurance Officer of GCPs for Clinical Development has the responsibility for overseeing and ensuring compliance with Ferrer's internal procedures and GCP in all assigned areas of responsibility achieving continuous improvement initiatives into the Quality System.
Responsibilities
General functions:
* Draft and review documentation related to their scope of application, including Plans, SOPs, or other controlled documents for the performance of duties within the Quality Assurance Department, and ensure they are up-to-date and current.
* Define, develop, implement, and monitor quality indicators (Key Quality Indicators - KQIs) to measure the proper functioning of the Quality System. Ensure the KQIs implementation.
* Participate in change control, ensuring traceability and proper implementation of these changes in compliance with data integrity practices.
Specific GCP Functions:
* Ensure initial and ongoing training in GCPs. Manage training for the department through the Training Matrix.
* Oversee the GCP document management system within its scope of application.
* Participate in the investigation of GCP deviations and non-conformities, including the management of CAPAs resulting from such deviations.
* Maintain and implement the Clinical audit strategy based on risk analysis.
* Perform the qualification/approval and periodic monitoring of Clinical Development Service Providers (CROs, vendors, etc.) at the corporate level.
* Plan, schedule, conduct, and report on Clinical Development audits (GCP audits), acting as lead auditor and/or co-auditor.
* Manage the quality system for internal and external audits and inspections; track and monitor the status of observations and their corresponding CAPA corrective actions.
* Act as support for closure by monitoring preventive and corrective actions in the Clinical Development area and evaluating their effectiveness.
* Share and/or escalate audit and inspection findings and learning with relevant functional units and management.
* Prepare and support external audits and inspections in the Clinical Development area.
* Act as advisor between/with functional units and collaborators to promote standardization, improve communication, and enhance the efficiency of quality systems through cooperation.
* Act as an advisor on issues related to the quality system, regulations, GCP and regulatory compliance.
* Contribute to strategic company and Product Development projects. Coordination, execution, and reporting of Due Diligences.
* Participate in different projects that affect or may affect GCPs compliance.
* Management and implementation of the Preclinical Research Quality System in collaboration with the Quality Assurance R&D team, primarily focused on development and maintenance of SOPs, supplier approval and monitoring, and GLP audits.
Why Ferrer?
* Make a positive impact in society
* Participate in volunteering activities
* Grow in a culture of trust, responsibility, and constructive feedback
* Enjoy a flexible working model & collaborative office experience to enable innovation and teamworking
* Make a real difference to the team and to yourself
* Take advantage of opportunities for development & learning
* Discover a range of benefits to support your physical, emotional and financial wellbeing
* Customize your remuneration and benefit
Requirements:
What You’ll Need To Succeed
You will rock at this company if you are a person with empathy, humility, curiosity and optimism.
You will rock at this role if you match with:
* University degree in life science or healthcare (pharmacy, biology, medicine…)
* Pharmaceutical Quality Assurance and/or GCP training courses.
* Master related to Clinical Trials is highly valuable.
* Previous experience:
o More than 5 years experience in GCPs in Pharmaceutical Industry or equivalent.
o Experience in GxP regulated activities (QA, GCP auditor, Clinical development, CRA…)
* English Advanced Level (oral and writing)
* Good Pharmacovigilance Practices (GVPs)
* Good Laboratory Practices (GLPs)
* Knowledge of computer systems validation (CSV)
* Ability to work independently as a GCP auditor.
* Capabilities of management of clinical development projects.
If this great challenge matches your profile, then we are waiting for you!
At Ferrer, we guarantee equal treatment and opportunities in recruitment, avoiding prejudices and stereotypes for any reason in the processes of access to the company, assessing only objective criteria such as professional and academic skills and work experience.
Seniority level
* Seniority level
Not Applicable
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
* Industries
Pharmaceutical Manufacturing
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