Lead GMP Quality Control Specialist
2 weeks ago
Job Summary:
eXmoor Pharma Concepts Limited is seeking an experienced Lead GMP Quality Control Specialist to join our team. As a key member of our Quality Control department, you will be responsible for ensuring that our analytical services laboratories operate to a GMP standard, meeting all local and regulatory requirements.
Main Responsibilities:
- Supervise and manage GMP QC staff, including Senior QC Scientists and QC Scientists, to ensure they perform their roles effectively.
- Develop and implement systems for reporting QC testing data to QA, ensuring timely completion of quality records and metrics reporting.
- Lead OOS/OOT investigations and support QC staff in completing these records, working closely with Production and QA teams to drive closure.
- Take the lead in completing quality risk assessments related to QC and develop systems for communicating in-process testing data with the Production team.
- Set up and manage systems for trending critical quality attributes and schedule/manage all QC sample testing for raw materials, in-process, and final product/stability test samples.
Requirements:
- Minimum BSc level education in a relevant subject area or equivalent years of experience.
- Considerable experience (4+ years) working within GMP QC Operations.
- Good understanding of Good Manufacturing Practice as applied to small-scale biopharmaceuticals and Cell & Gene Therapies for clinical trials.
- Technical expertise in analytics related to ATMPs, including HPLC, FACS, PCR, qPCR, etc.
- Experience managing a team of QC Scientists, including leading, developing, motivating, and organizing.
- Aptitude for coaching and mentoring a team.
eXmoor Pharma Concepts Limited is a globally recognized team of scientists, consultants, and engineers providing translation consultancy, process development services, capital project design, licensing, and GMP manufacturing for early-phase clinical trials.
Why Join Our Team:
- Opportunity to work on a wide range of client projects in a rapidly growing business.
- Develop your quality management career in a dynamic and supportive environment.
- Collaborate with a globally recognized team of experts in the biopharmaceutical and Cell & Gene Therapy industries.
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