Senior GCP Process Auditor

This is a fully remote position, open to applicants in Hungary.

📋 Description

• Assist in the maintenance of the Quality Management System, encompassing SOPs, training, and CAPA.

• Manage and process documentation for controlled documents as necessary.

• Design and facilitate training programs for employees and/or consultants.

• Conduct client/sponsor audits and aid in regulatory inspections.

• Organize and perform assessments of potential and contracted vendors, including conducting vendor audits as needed.

• Organize and execute internal audits of quality systems.

• Organize and carry out investigator site audits.

• Organize and conduct audits of trial master files.

• Engage in computer systems validation projects and oversee the systems change control process.

• Offer QA consultation and support to both internal and external project teams.

• Manage and respond to reported quality issues along with any related corrective and preventive actions.

• Oversee quality systems to provide insights on compliance risks to QA management and identify areas for improvement.

• Maintain quality and compliance trackers, databases, metrics, and files.

• Adhere to relevant regulations and standards, including but not limited to local regulations (US FDA and EU), ICH, and company policies and procedures.

⛳️ Requirements

• The ideal candidate should possess extensive working knowledge in managing various types of audits, especially GCP Process Audits; applications from candidates without this experience cannot be considered.

• Familiarity with GCP/ICH guidelines as well as FDA regulations and standards is required.

• A Bachelor’s degree in a science, healthcare, or a related field is required; a combination of qualifications and relevant experience may be accepted as an alternative.

• Must be available to travel up to 25% domestically and/or internationally.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Flexible work hours

• Paid time off

• Professional development opportunities