QP / Qualified Person - Anywhere in EU
- Experience Level
- QA and QC oversight of in house manufacturing, packaging and labelling
- QA/QC support for outsourced manufacturing, packaging and labelling
- QP certification of batches used in clinical trials
- Management of quality systems, e.g. deviations, complaints, CAPAs and change controls etc.
- Coordination of training
- Management of IT systems, e.g. Document Management System, Empower, Quality Manual, Learning Management System etc.
The Qualified Person will participate in development teams. As a team member he/she attends regular meetings and determines the quality strategy for the supply of clinical trial materials for the various clinical studies in close cooperation with other stakeholders. These activities include:
- Compiling/approving Technical/Quality Agreements.
- Follow-up on quality incidents and issues.
- Initiates/supports continual quality improvements.
- Certification of clinical trial materials.
- Pharmaceutical or analytical background with experience in biotechnology
- At least 3 years of experience as Qualified Person, preferably with clinical trial materials
- At least 3 years of experience with pharma/biotechnology manufacturing processes.
- Good communication and management skills to support the (global) project team activities and maintain good relationships with stakeholders.
- Capability to act in a corporate environment with changing and different priorities.
- Capability to operate within the quality requirements stated in the international GMP guidelines
- Good in reading, writing and speaking English
Freelance / 6-12month contract
Attractive pay rate
Anywhere in EU
ABOUT PLANET PHARMA
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.