Job description:
 

We want you to feel inspired every day. We’re future-focused and our business is growing. We succeed together through passion, commitment and teamwork, and so can you. 

We are currently recruiting for a Senior QA Officer to join the Quality Assurance team.  The main purpose of this role is to support manufacturing operations and product release.

Quality Assurance takes into account anything that could affect a drug’s quality during its research, development and manufacturing phases. We work across the whole product lifecycle. Our expertise spans all the good practice quality guidelines and regulations. We partner with most functions in the business. We make sure activities, processes and procedures satisfy compliance, product quality, patient safety and efficacy needs. We help the business to comply to current good practice quality guidelines and regulations, Regulatory and Product license and registered detail requirements. 

Your responsibilities in this role would be: 

• To be responsible for monitoring, advising and supporting operations to ensure regulatory compliance and to facilitate product release in a timely manner. 
• Oversee quality of GMP operations to ensure adequate and timely release of GMP compliant product. 
• Provide direct quality team support during customer and regulatory audits. 
• Ensures that BMRs are reviewed in a timely manner for on-time batch release. 

• Review quality systems documentation including Deviations, Change Controls and CAPA’s. 
• Assist different functions to Investigate problems to determine root cause and corrective and preventive actions. 
• Review documents in support of and equipment qualification and validation 
• Monitoring the progress of GMP processes through all departments to ensure compliance with specifications and GMP. 
• Participate in continuous improvement initiatives to enhance working practices and to mitigate quality risks. 

• Supporting Quality based projects working as part of a multidisciplinary team as required. 
• Promoting continuous improvement of the Quality Management System. 
• Ensure that all sites follow all SOPs which ensure that health, safety, environmental, quality standards are met. 
• Ensuring the effective communication of key information affecting product release to all relevant parties. 
• Reports on-going progress with QA activities and Deviations to QA Team Lead. 

We are looking for: 

• A level or National Certificate in a Science discipline. 
• Higher National Certificate or Degree in science discipline desirable. 
• Significant experience working within Pharmaceutical QA
• Solid working knowledge of GMP & Quality related pharmaceutical regulations & standards including cleanroom design, classification and environmental control / monitoring. 

• Experience of MHRA and or customer / client inspections. 
• Experience of having worked in an ATMP / Biologics Manufacturing environment preferable. 
• Computer literate (Word, Excel, MS Office) 
• Understanding & experience of GMP and pharmaceutical industry QA requirements. 
• Excellent attention to detail. 

• Good team player, and must also be able to work alone. 
• Good interpersonal and communication skills. 

About Us: 

We are an innovative leading viral vector specialist focused on delivering life changing therapies to patients. 

Our innovative solutions and proven expertise allow us and our customers, the biotech and biopharma industry, to deliver life-saving therapies to reach even more patients. 

The success of cell and gene therapy products transforms outcomes for millions of people suffering from some of the world’s worst diseases and medical conditions. 

We work together, motivated to make a difference, and so can you.  

What’s in it for you: 

• Highly competitive reward packages 
• Wellbeing programmes 
• Development opportunities 
• A 35-hour working week 

• Welcoming, friendly, supportive colleagues 
• A diverse and inclusive working environment 
• Our values are: Deliver Innovation, Be Inspiring and Have Integrity 
• State of the art laboratory and manufacturing facilities 

We want you to feel inspired every day. We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment and teamwork, and so can you. 

Collaborate. Contribute. Change lives 

No agencies please

We offer:

We are a pioneering gene therapy business, and our mission is delivering life changing gene therapies to patients. We work together, motivated to make a difference, and so can you.

We are pioneers; no one else does what we do.

Gene therapy is the treatment of disease by the delivery of therapeutic DNA into a patient’s cells. It is transforming medicine as we know it, long term and potentially curative treatments for a wide range of diseases are now possible.

We are at the forefront of this exciting area. We have a strong reputation in gene therapy, with world leading expertise in lentiviral vectors. We have a leading, integrated platform of exclusive technologies to design, develop and bioprocess unique gene based medicines, both in house and with partners.

We drive credible science to realise incredible results.

Whether you’re motivated by the discovery and development of product candidates within Research, or by cutting edge tools and technologies including AI and automation of our contract development and manufacturing organisation, we can offer you a career like no other. We are excited about our future. Join us and change lives.