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Do you pride yourself on your integrity? We do what’s right for employees, patients, and partners, and so can you.
We are currently recruiting for a Quality Systems Officer to join the Quality Assurance team. The purpose of this role is to oversee the Training System, work with departmental Training Delegates, ensure training compliance and provide improvements.
Oxford Biomedica’s Quality Assurance (QA) team is responsible for the company’s quality processes and systems, in compliance with GMP guidelines. The team are accountable for internal and external audits, quality compliance and control.
Your responsibilities in this role would be:
Management of current Training System and procedures
Ensure compliance in Training System for new starters and leavers
Monitor and produce training metrics of GMP compliance
Prepare and conduct reviews of QA training folders
Support and co-ordinate responses to audits and inspections
Create and maintain a state of readiness to satisfy expectations during audits and inspections.
Work in a team to prepare and ensure the site systems are compliant and meet GxP and Quality expectations.
Ensure that the manufacturing and analytics sites follow all SOPs which ensure that health, safety, environmental, quality standards are met.
Ensuring and coordinating training in all aspects of Quality Management Systems and Quality related GMP, including procedural updates.
We are looking for:
A level or National Certificate in a Science discipline
Higher National Certificate or Degree in science discipline desirable
In depth knowledge and understanding of GMP compliance in pharmaceutical industry
Awareness and understanding of Quality Systems to support them effectively.
Strong verbal and written communication skills
Previous experience in Python coding and Veeva Vault is desirable
About Us:
Oxford Biomedica is a quality and innovation-led viral vector CDMO with a mission to enable its clients to deliver life changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, we have more than 25 years of experience in viral vectors; the driving force behind the majority of gene therapies.
Oxford Biomedica collaborates with some of the world’s most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. Oxford Biomedica’s world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatory expertise.
What’s in it for you:
Highly competitive total reward packages
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
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