Contract QP ATMPs

Walker Cole International is currently partnered with a Biopharmaceutical business who is on the trajectory for continued growth. To support the exceptional increase in workload and plans for growth, we are searching for an oncoming hire of Contract QP in South England for a contract of 12 months initially for 2025.

The ideal candidate will have the following responsibilities:

• QP in accordance as per licence requirements.
• Batch certification and release duties of Investigational Medicinal Products (IMPs) and Advanced Therapy Medicinal Products (ATMPs) ensuring compliance with current and emerging regulatory requirements
• Quality improvement projects and supporting periodic quality reviews.
• Manage QP activities including partial batch manufacture, clinical trial labelling, and final certification.
• Communicate quality and regulatory updates to the Senior Management team.
• Provide Quality oversight on high profile projects.
• Overseeing BMR and supporting record review and approval (deviations, EM, analytical, OOS/OOT etc)Maintain QMS oversight as part of QP operational responsibilities (EU GMP Annex16)

The ideal candidate will have the following skills/experience:

• In depth knowledge and experience of both QA and QP (batch release)
• Hands-on experience of ATMPs 
• Can-do attitude and eager to learn
• Availability from 2025 onwards

Contract details:

• Start date: 2025 
• 1-2 days per week 
• On-site - non-hybrid role
• £1000-1400 per day (dependent on experience level)
• Duration of project: 12 months (with possible extension)
• Location: South England 

QP l Qualified Person l Quality Assurance l Operations l Quality l CAPA l Deviation l Change Control l Gap Assessment l Contract l Contractor l Biopharma l Steriles l ATMP l