Management Team
Piera Lukes - Managing Director
Piera has been working in QA since 1996 and has conducted a variety of GCP in the different areas of clinical development, throughout Europe, Africa, and America including Phase I-IV and PMS/SAMM studies. Piera has worked as a consultant since 1999 with several clients in the pharmaceutical, CRO and IT industries. Piera speaks fluent Italian and English, can read and communicate in Spanish, and has basic get by knowledge in French. Piera is also the founder and the managing director of IT'sQA.
Anna Peplinska - Quality Manager
Anna has been working in clinical and pre-clinical QA since 1989 within the CRO and Pharmaceutical industry. Her experience includes conducting various audits in the different areas of clinical development as well as setting up QA and SOP systems, training programs and preparing and facilitating regulatory inspections. With IT'sQA, Anna has actively contributed towards the development of the IT'sQA excellence QMS model that has now been implemented in several companies. Anna is currently the Quality Manager for IT’sQA.
Rehema Kabalan - Operations Manager
Rehema has been working in QA since 2003 within the pharmaceutical industry. Her experience extends to auditing and coordinating GCP investigator site audits (globally), conducting internal reviews, Regulatory Agency inspection readiness, integration of merged companies, Pharmacovigilance support, maintenance and management of SOP systems and training programmes (across Europe). She is currently the Operations Manager for IT’sQA.
Consultants
The consultants selected to be part of the IT'sQA network are selected and qualified on the basis of historical performance, either within the company or from personal past working relationships, recommendations or interviews.
The number of consultants joining the network is constantly expanding. CVs of consultants will be made available prior to them becoming involved in a project.