Cell and Gene Therapy Auditor

Cell and Gene Therapy Auditor - Fantastic rates

Hybrid work with 1 week in EU onsite – Excellent day rate (3 weeks) Dahlia recruitment is working in partnership with an expanding Life Science business to recruit for an experienced auditor with a passion for advancing cell therapy and ATMPs. A leading Contract Development and Manufacturing Organisation (CDMO) is seeking skilled professionals to join their team in January / February 2025.

This role offers a unique chance to contribute to ground breaking Phase 1 immunotherapy (CAR-T) clinical trials, with the backing of FDA and MHRA approvals. Key Responsibilities- Conduct comprehensive audits focusing on GMP compliance, including facility and environmental monitoring, HVAC systems, and system qualification.- Evaluate quality systems, ensuring robust documentation, effective quality management, and adherence to 21CFRPart 11 compliance and data security protocols.- Oversee analytical testing processes, from method development to validation and life cycle management of assays.- Provide a holistic review of the entire facility and its personnel, beyond just the medicinal product or device. Essential Skills and Experience- Proven experience in auditing cell therapy or ATMP environments.- In-depth knowledge of FDA, EU, and MHRA guidelines.- Expertise in GMP, quality systems, and analytical testing.- Ability to maintain a systematic overview, ensuring comprehensive facility and personnel assessments. This role will be working along side the Quality Auditor to complete the overall Audit with this role having an Analytical testing focus. This role is ideal for contract professionals who are detail-oriented, possess strong analytical skills, and have a deep understanding of regulatory requirements. Please follow our page for new roles and insights

Dahlia Life Sciences