Senior Quality Control Specialist / GCP Auditor

Senior Quality Control Specialist / GCP Auditor

Primary Location Europe

Job ID: QA_MOS_QAS-2908

Job Type: Full-Time

Job Description

Your main responsibilities

• Perform internal, vendor, project and clinical site audits in accordance with the annual audit program to ensure compliance with regulatory requirements and GCP standards.
• Conduct triggered or “for cause” audits to ensure regulatory and quality risks are effectively identified and mitigated.
• Work with process owners and subject matter experts to conduct root cause analysis of audit findings.
• Provide expert advice on Quality and regulatory requirements and work with stakeholders across the organization to identify and implement appropriate corrective and preventive actions (CAPA) following audit findings and other quality events.
• Monitor actions related to audit findings and close audits once evidence of all actions are completed.
• Lead specific workstreams as part of the development of the annual audit program.
• Oversee the vendor assessment and monitoring process, to ensure regulatory and quality standards are maintained.
• Undertake any necessary preparation for regulatory inspections and third-party audits as required.
• Assist the Head of Quality Management with hosting of Clients or collaborator audits.
• Support the operation of management review meetings including preparation of Quality reports, ensuring accurate and appropriate information is provided to assist senior management decision-making.
• Provide expert Quality and Good Clinical Practice advice across the organization, to ensure company-wide awareness and continuous improvement.
• Promote a culture of quality and continuous improvement throughout the organization.

Qualifications

• At least 3 years of GCP auditing experience.
• 5+ years of GCP/Pharmaceutical Industry/Health Authority experience or equivalent.
• 5+ years of Clinical Monitoring experience.
• A degree in life sciences, medical sciences, pharmaceutical field or similar and in management.
• Knowledge of ICH GxP and ISO regulations.
• Knowledge of ICH GCP and national regulations related to clinical trials.
• Ability to independently manage and objectively evaluate complex compliance issues with minimal supervision.
• Flexibility and willingness to travel up to 60%.
• Fluency in English is essential – written and spoken.

Benefits

• Competitive salary and benefits.
• Flexible working arrangements.
• Career opportunities at local, regional and global levels.
• Support for personal and professional development (trainings, coaching, career development, international assignments, etc).

We provide equal opportunity to all qualified applicants and employees by prohibiting discrimination in employment decisions because of race, color, religion, sex, national origin, age, veteran status or disability.

If you are ready to start your journey at Cromos Pharma, please send your CV to

Cromos Pharma is an international contract research organization delivering integrated clinical research solutions that accelerate drug development.