Quality assurance specialist at a GMP certified pharmaceutical manufacturer.Duties:Co-management of quality assurance department with quality assurance manager.Coordination of site equipment and system validation/revalidation and metrological testing/calibration.Preparation of validation documents and supervision or execution of validation for site equipment and systems.Preparation and supervision of preparation of quality management system documentation (department standard operating procedures, master batch records, packaging batch records).Execution of internal audits.Supplier evaluation.Preparation of process and cleaning validation protocols.Management of change control.Preparation of risk analysis, deviation, corrective and preventative action protocols.

Management of a GMP certified chemical quality control laboratory that was part of a pharmaceutical manufacturing plant.Duties: Management of chemical laboratory staff, job supervision, training and hiring.Purchase of reagents and or equipment and organization of equipment maintenance, metrological testing/calibration and revalidation.Preparation of standard operating procedures, method validation protocols, analytical protocols and equipment revalidation protocols.Active pharmaceutical ingredient manufacturer drug master file review.Drug product dossier review.

Chemical analysis and quality control of pharmaceutical products and raw materials.

Molecular analysis of clinical brain tumor samples.