QA Validation Consultant is required for an innovative and rapidly growing Biopharmaceutical company in Limerick. The new facility is close to completion and is responsible for the production, packaging, labelling and delivery of biopharmaceutical medicines for global markets. The company currently markets medicines for various diseases and has a rich pipeline of products.
The team on site strive to create a culture of trust, teamwork, transparency, respect and a drive to continuously improve. This organization has an exceptional reputation based on commitment to their employees, culture and patients and have won several #1 employer awards.
If you want to succeed on a new and growing site, with innovative medicines and in an atmosphere which is intense, face paced and exciting then this is the opportunity for you .
Excellent opportunity for a QA Validation Consultant with responsibility for ensuring:
o Generation, review and approval of IOPQ protocols and assocaited validation documents and supervision on execution activities Lab systems and related operational software packages.
o Implementation of the qualification program for initial qualification of laboratory and/ or manufacturing equipment, at the Raheen, Limerick bulk biologics facility.
o This includes document preparation for:
o Equipment qualification Assessments (EQAA)
o Installation Qualifications (IQs), Opeational qualifications (OQs) and where applicable Performance Qualifications (PQs).
The QA Validation Consultant requires:
o Experience in Lab Equipment/System Validation Activities
o Third level education BSc or BEng
o 3 + year experience in Biotechnology or pharma
Call Kathy in LSC on 021 4777 329 to discuss this new QA Validation Consultant role in more detail or apply directly via this advert.