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Senior QA Specialist – Biopharmaceutical GMP

Business Type: Biotechnology Company
Job Type: Bioengineering
Job Level: Management
Position: Full Time
Salary: Excellent Salary and Benefits Package
Location: Hertfordshire
Reference: J16081a
Closing Date: 05/05/19
Job Details:
4 new positions have been created in Stevenage for Senior QA professionals with a life science degree or higher (Pharmaceutical Science, Immunology or similar), leadership skills and significant industrial experience in a Quality-based role. You will join a genuinely exciting and unique organisation involved in the manufacture of Advanced Therapy Medicinal Products and Gene Therapies to treat cancer. You will have leadership responsibilities within a small QA team and have significant input into developing a QMS for GMP in a multi-product facility that delivers cell and gene therapies for clinical trials. The company is offering an excellent salary and benefits package and this will be a great opportunity to progress your career within a growing business.
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 3 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 / sterile 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:
  • Line management and training of less experienced QA colleagues
  • Review and qualification (or disqualification) of starting material and critical raw material suppliers, including audits and desk-based reviews
  • Continuous improvement of the Pharmaceutical Quality System (PQS)
  • Operator training and competency assessment systems
  • Process qualification and validation, including sterile processes
  • Analytical and Quality Control assay validation
  • Manufacturing authorisation management, including GMP licence variations
  • Clinical Trial Authorisation management, including amendments to Investigational Medicinal Product Dossiers
  • Drug Product release following batch certification
  • Retention and reference sample management and control of release for use in investigations
  • Real-time review of Batch Manufacturing Records and Quality Control records
  • Conducting self-assessments in accordance with a defined schedule
  • 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
  • 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), 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 have a PhD, MSc or BSc in Pharmaceutical Sciences, Immunology or similar, combined with significant QA management experience gained in a commercial GMP / sterile Biopharmaceutical manufacturing facility. A strong understanding of sterile operations and practices would be a strong advantage. 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) is essential, as is having expertise in the manufacturing and testing procedures for advanced therapies.
Full details will be provided on application. Apply now!

Posted: 07/04/2019 | NPJ Ref: 233350
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