Projektbeschreibung
Senior Quality Assurance Auditor (m/w/d) (DE)
Constaff GmbH [15121]
For our client in Frankfurt we are looking for a Senior Quality Assurance Auditor (m/w/d). Tasks: ·Plan, conduct, document, and close audits to ensure compliance with regulatory requirements, customer requirements, and internal quality standards ·Evaluate audit findings and prepare and communicate audit reports ·Advise project teams, customers, and monitors on regulatory requirements, compliance matters, and audit findings ·Review and approve investigations, Root Cause Analyses (RCA), Corrective and Preventive Actions (CAPA), and Effectiveness Checks (EC) ·Track quality actions through to closure and manage quality-related events ·Conduct pre-inspection visits at clinical trial sites ·Review and improve policies, procedures, and quality processes ·Maintain the electronic Quality Management System (eQMS) and support the audit lifecycle ·Lead and contribute to Quality Assurance initiatives and process improvement projects ·Support training activities and the preparation and conduct of audits and regulatory inspections ·Deliver Quality Assurance consulting services and client projects within agreed budgets and timelines Requirements: ·Bachelor's degree preferred. ·Several years of professional experience in the pharmaceutical, technical, or a related industry ·Experience in Quality Assurance Audits and relevant GCP knowledge, or an equivalent combination of education, training, and experience ·Experience conducting GCP audits at clinical trial investigator sites (Investigator Site Audits) ·Extensive knowledge of pharmaceutical development processes, regulatory requirements, and Quality Assurance processes ·Strong communication, interpersonal, and teamwork skills, with the ability to collaborate effectively with various stakeholders ·Excellent problem-solving, risk analysis, and negotiation skills ·Ability to work independently and in a structured manner, deliver training, and manage multiple projects simultaneously ·Proficiency in word-processing, spreadsheet, and database applications ·Willingness to travel 30–50% of the time, mainly within Europe ·Experience auditing Clinical Study Reports (CSRs), Trial Master Files (TMFs), and clinical trial data management is an advantage ·Fluent in English and good knowledge of German Based on customer specifications, a project-related employment is aimed for Are you currently interested and available? Then please feel free to contact us anytime.
- Plan, conduct, document, and close audits to ensure compliance with regulatory requirements, customer requirements, and internal quality standards
- Evaluate audit findings and prepare and communicate audit reports
- Advise project teams, customers, and monitors on regulatory requirements, compliance matters, and audit findings
- Review and approve investigations, Root Cause Analyses (RCA), Corrective and Preventive Actions (CAPA), and Effectiveness Checks (EC)
- Track quality actions through to closure and manage quality-related events
- Conduct pre-inspection visits at clinical trial sites
- Review and improve policies, procedures, and quality processes
- Maintain the electronic Quality Management System (eQMS) and support the audit lifecycle
- Lead and contribute to Quality Assurance initiatives and process improvement projects
- Support training activities and the preparation and conduct of audits and regulatory inspections
- Deliver Quality Assurance consulting services and client projects within agreed budgets and timelines
- Bachelor's degree preferred.
- Several years of professional experience in the pharmaceutical, technical, or a related industry
- Experience in Quality Assurance Audits and relevant GCP knowledge, or an equivalent combination of education, training, and experience
- Experience conducting GCP audits at clinical trial investigator sites (Investigator Site Audits)
- Extensive knowledge of pharmaceutical development processes, regulatory requirements, and Quality Assurance processes
- Strong communication, interpersonal, and teamwork skills, with the ability to collaborate effectively with various stakeholders
- Excellent problem-solving, risk analysis, and negotiation skills
- Ability to work independently and in a structured manner, deliver training, and manage multiple projects simultaneously
- Proficiency in word-processing, spreadsheet, and database applications
- Willingness to travel 30–50% of the time, mainly within Europe
- Experience auditing Clinical Study Reports (CSRs), Trial Master Files (TMFs), and clinical trial data management is an advantage
- Fluent in English and good knowledge of German
Julia Barth