QA Specialist - Biopharmaceutical GMP

Posted 12 June by Next Phase Recruitment
Easy Apply
Do you have a biology-based background and some QA experience gained in a highly regulated Pharmaceutical or Biotech environment? A series of positions have been created in Stevenage, Hertfordshire, for ambitious and personable QA professionals with a life science degree or higher (Pharmaceutical Science, Immunology or similar) and some industrial experience in a Quality-based role, preferably relating to sterile biomanufacturing.

You will join a genuinely exciting and unique organisation involved in the manufacture of Advanced Therapy Medicinal Products and Gene Therapies to treat cancer. The company is offering an excellent salary and benefits package (to discuss on application, but around the "early to mid 30s" depending on experience) and this will be a great career opportunity for someone with a passion for scientific innovation and GMP Quality Assurance.

The Company

A pioneering and ambitious Biopharmaceutical company who develop next-generation, programmed T-cell therapies to treat cancer. The organisation has existed for 5 years and is very well funded, with a clear strategy and expansion plan for the next 4 years and beyond. Scientifically, the company has extremely exciting technologies, using a broad suite of proprietary and modular T-cell programming to engineer precisely targeted, controlled and highly active T cells. Commercially, they have a pipeline of product candidates in development (for the treatment of haematological malignancies and solid tumours) and is increasing its GMP production capacity. Based in a state-of-the-art facility in Stevenage, Hertfordshire, you will join a team that is doing something genuinely meaningful.

The Role

This is a varied and exciting role which will include the following:

• Documentation management, including GMP / sterile policies, procedures, Production and Quality
• Control (QC) records / pro-formas, and Pharmaceutical Quality System (PQS) templates
• Record review (Environmental Monitoring (EM), Production and QC)
• Planned preventative maintenance and equipment calibration management
• Materials review and release for use in Production and QC
• Starting material and critical raw material sample management and retention
• Conducting self-assessments
• Deviation management within a PQS including coordinating change controls, quality exceptions, microbiological out-of-trend and out-of-specification results and other environmental excursions
• Equipment and facilities validation and revalidation protocols and maintenance
• Assessment and qualification (or disqualification) of raw material suppliers, including audits
• Audits of GMP contractors conducting outsourced activities
• Product Quality Review
• Risk assessments with respect to product quality and health and safety


In addition to a competitive salary (negotiable depending on experience) and excellent career progression opportunities, the company offers a very good benefits package including:

• 25 days annual leave
• Excellent pension scheme
• Life assurance (4 times basic salary)
• Group Income Protection
• Private Medical Insurance (paid for by the company for yourself only)
• Eye care vouchers


The successful candidate will ideally have a BSc (MSc preferred) in Pharmaceutical Sciences, Immunology or similar, combined with some experience gained in a commercial GMP facility, preferably relating to sterile biopharmaceutical manufacturing. You will need to have excellent people skills, the communication to communicate with colleagues and external partners at all levels, and first-rate organisational skills. Experience with MHRA and HTA inspections (either as a host or involved contract giver to a manufacturing site) would be a strong advantage but is not essential. Above all else, you must have a passion for GMP Quality Assurance and a desire to learn about innovative T cell cancer treatments.

The company is also recruiting for Senior Quality Specialists, in case your experience is more extensive than the experience required for this position.

Full details will be provided on application. Apply now!

Reference: 38205619

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