Helena is a leading Commissioning, Qualification and Validation Subject Matter Experts with almost 20 years’ experience in the life sciences sector. With a Master’s in Quality and Regulation, she has significant experience in CQV project planning, compliance/ data integrity, temperature mapping, and coordination, and an in depth understanding of aseptic processing, biotechnology products, sterile filling, oral solid dosages, lab equipment and medical devices. Helena applies her understanding of FDA regulations, regulatory guidance documents, and ICH guidelines to products/ processes, to develop and implement risk-based approaches and test plans to ensure product quality. She has implemented improvements for clients based on her analysis, and by utilising her communication skills, led and managed a wide range of (technical/ non-technical) teams whilst providing mentoring, coaching and support. Her adaptability and prioritisation skills allow her to deliver system/ equipment commissioning, qualification, validation, verification and project management effectively.
|Project Experience History|
|Client||Facility Type||Cost (€MM)|
|Pfizer||Oral Solid Dose||<100|
|Novartis||All (Global Hub)||<75|