Senior Quality Assurance Specialist

Job title: Senior Quality Assurance Specialist

Reporting to: Head of Quality

Department: GMP

No of Direct reports: 1-2

Location: Bristol

Summary

eXmoor Pharma is the only integrated cell and gene therapy CDMO with over 20 years of consultancy expertise embedded across every stage of the CMC journey — from early-phase strategy to process development, GMP manufacturing and commercialisation. We provide comprehensive support across Viral Vectors, Autologous and Allogeneic Cell Therapies, and RNA technologies. This integrated model enables seamless progression from early-phase strategy through to commercial readiness

The Senior QA Specialists will be instrumental in the development of clinical and commercial manufacturing capability for eXmoor’s GMP manufacturing capability.

This is an exciting opportunity to work with eXmoor’s globally recognised team of scientists, consultants and engineers. You will work on a wide range of Client projects in a rapidly growing business whilst developing your GMP manufacturing career.

Job Purpose

The GMP manufacturing facility is capable of handling a wide range of cell and gene therapies as well as small scale complex biologics. The eXmoor facility is comprised of the following technical areas: Process Development (PD), Analytical Services (AS) including both GMP QC and Analytical Development and GMP clinical phase production, including a small fill/finish capability. These teams work closely together such that processes developed in the PD area will be transferred at scale to the GMP suites.

The Quality Assurance Specialists will provide quality support across the Pharmaceutical Quality System (PQS), third party supplier management: production and QC testing activities, training and validation activities and be instrumental in the development and operation of eXmoor’s Pharmaceutical Quality System.

Main areas of responsibility / key duties

• You will conduct your duties to the highest quality standard and in a safe way complying with all policies and procedures and with due care and attention for yourself and your peers.
• You will support the Head of Quality in the operation & oversite of the Pharmaceutical Quality Systems including deviation and faults, change control, validation activities, Out of Specification results and self-inspections.
• You will perform production batch & QC test reviews.
• You will maintain a compliant documentation control system including policies, standard operating procedures, batch manufacturing records, validation protocols and quality control reports
• You will ensure timely investigation and closure of deviation, faults, audit findings and out of specification results.
• You will complete a regular review and documentation of CAPAs, ensuring effectiveness of corrective actions.
• You will complete a regular review and QA management of Change Controls.
• You will support regular QA review meetings.
• You will provide QA review and guidance to project teams to ensure delivery of GMP compliant manufacturing processes and drug products that are fit for purpose.
• You will perform vendor qualifications and audits, as well as self-inspections.
• You will keep abreast of changes to regulations and guidelines, advising the quality team on implications
• You will comply with lab documentation including Risk assessments, SOPs, COSHH
• forms, lab notebooks and records.
• You will ensure relevant training of staff on QA procedures and regulatory guidelines.
• You will prepare and lead internal and/or third-party supplier audits.

Person Specification

Essential Qualifications & Experience

• MSc or equivalent degree level education in relevant subject area or equivalent experience
• At least 2 years practical experience in Pharmaceutical Production or Quality Control plus 1 year in quality management, with necessary training relating to the ATMP products being manufactured.
• Implementation and management of a GMP Quality System within a manufacturing organisation for sterile biologics medicinal products.
• Risk management and application of risk management tools within GMP.
• Experience working in a regulated environment for example: MHRA, FDA, HTA.
• Excellent understanding of legislation and guidance documents relating to the manufacture of Advanced Therapy Investigational & Medicinal Products.

Desirable Qualifications & Experience

• Formal Quality Risk Management Training

Competences Required

• Organisation, planning and time management
• Oral and written communication skills
• Teamworking
• Innovation, inquisitiveness, and willingness to learn
• Attention to detail and getting things finished
• Problem solving
• Building constructive relationships and earning respect
• Motivated by growing a bio-technology business in the CGT / biopharmaceutical market
• Proficiency in Office365 (including Word, Excel, PowerPoint).

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