Main Duties & Responsibilities

• Conduct internal audits (both study specific and Quality System related) and coordinate inspections by external auditors, according to GCP and GLP regulations.
• Manage and execute corrective and preventive actions (CAPA).
• Prepare and organize documentation of Quality System (SOPs, forms, training records, etc.).
• Participate in the validation of computerized systems.
• Actively support QAU Director in evaluating and implementing new department and Company processes.

Required Profile & Qualifications

• BSc or MSc in life sciences.
• Experience working under GLP and GCP regulations will be greatly valued.
• Fluent written and spoken English.
• Proficiency in MS-Office, especially Word and Excel.
• Knowledge of bioanalytical techniques (LBA, LC-MS/MS) will also be valued.

Other Required Skills

• Good organizati...