Senior GCP Process Auditor

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

📋 Description

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

• Process and keep documentation for controlled documents as necessary.

• Create and oversee training programs for staff and/or consultants.

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

• Organize and perform evaluations of potential and contracted vendors, including necessary vendor audits.

• Manage and execute internal audits of quality systems.

• Coordinate and carry out audits of investigator sites.

• Oversee and conduct audits of trial master files.

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

• Offer QA consultation and support to assigned project teams, both internally and externally.

• Address and oversee reported quality issues along with any related corrective and preventive actions.

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

• Maintain Quality & 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

• In-depth, practical knowledge of managing all types of audits, particularly GCP Process Audits.

• Familiarity with GCP/ICH guidelines and FDA regulations and standards.

• Bachelor’s degree in a scientific, healthcare, or related field of study; a combination of qualifications and equivalent relevant experience may be considered as an alternative.

• Willingness to travel up to 25% domestically and/or internationally.

• Experience in a CRO environment is preferred.

• QA certification is preferred (e.g., CQA, SQA, etc.).

• Experience with electronic clinical trial systems (e.g., EDC, CTMS, IxRS, ePRO, etc.).

🏝️ Benefits

• Opportunities for professional development.

• Flexible working hours.