We are at the centre of the rapidly growing cell and gene therapy sector. We deliver life-changing therapies to patients, and so can you.
We are currently recruiting for a QC Team Lead Chemistry to join the Analytical Development and QC (ADQC) Team. The purpose of this role is to effectively manage a team of QC Raw Material Technicians & Chemists to ensure timely reporting of analytical data, manage outsourced QC testing and provide oversight of GMP compliance.
Our ADQC Team supports the development of products through analytical testing to facilitate manufacturing and process development, ensuring appropriate quality controls and use of analytics. The QC Team Lead role is office and lab based.
Your responsibilities in this role would be:
1. Provide leadership and direction for the team of incoming raw material Technicians and QC chemistry Technical Specialists.
2. Organise and plan the workload for the team and generate a weekly schedule.
3. Author and technically review controlled documents (e.g. SOPs, QC testing documents, sampling plans, etc.).
4. Lead RCA and OOS / OOT / OOE investigations as SME.
5. QC checking of GMP documentation (e.g. external quality reports, assay paperwork, etc.).
6. SME review of Quality Records (e.g. Deviations, Investigations, Change Controls, CAPAs) in a timely manner.
7. Management of external testing and reporting and liaising with external testing labs as the first point of contact for any queries.
8. Effective management of client communication e.g., providing customer service and responding to questions.
9. Management of the control of QC processes.
10. Trouble shooting for QC activities.
We are looking for:
1. Educated to degree level within Life Sciences and experience working within a pharmaceutical regulated environment.
2. Understanding of GMP and knowledge of QC testing within a GMP environment.
3. Understanding of the Quality Management System.
4. Thinking critically and analytically and able to problem solve.
5. Computer literate (Word, Excel, MS Office).
6. Good interpersonal and communication skills (written and verbal).
7. Highly organised and motivated with excellent attention to detail.
8. Ability to work both independently and alongside members of OXB.
9. Self-motivated and able to motivate others.
Collaborate. Contribute. Change lives.
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