Qualified Person (QP)
Nollaig has over 15 years’ success as a contract Qualified Person across IMP and Commercial Product Licenses and across solid oral dosage and sterile products. In that time, she also released mAbs to US clinical trials on behalf of the sponsor. In parallel she has provided consultancy in the areas of Quality Systems, Compliance and the paradigm of product/ process development and validation. While actively operating as a contract Qualified Person, the associated roles gave Nollaig significant exposure to Quality, Technical, Compliance and Regulatory challenges and in particular she has lead manufacturing sites through a number of competent authority audits. Nollaig has held roles with Pharmacia Upjohn and Elan and as a consultant has had clients ranging from small development solid oral dosage and biotech companies to larger commercial stage companies.