Main Duties & Responsibilities
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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