Quality Assurance Officer

The RxCelerate group provides a platform for out-sourced drug discovery and development services and has a client base ranging from virtual biotech companies to multinational pharmaceutical companies.

We design and deliver complete drug development programmes and project management for our clients from inception through to Phase I clinical studies.</p><p>We are currently looking to recruit a Quality Assurance Officer to support our GxP team in our new building on the Babraham Research Campus. This is an exciting time to join our team as we scale up to support our growing global footprint and client base. Our numerous success stories speak for themselves as we have become the drug developer of choice for many of the UK’s top venture backed biotech start-ups.

The Role

Quality Assurance Manager will have responsibility for maintaining high standards of cGxP quality and ensuring compliance requirements are met.  An additional responsibility of this position will be the role of the archivist for RxCelerate’s cGxP activities. The ability to prioritise work and deliver within a dynamic and demanding scientific environment to meet challenging deadlines is essential.

Main Responsibilities

  • Act as the primary source for quality assurance in the company
  • Define the audit schedule; co-ordinate and carry out audits as required
  • Review SOPs and controlled documents to ensure compliance
  • Act as a point of contact for compliance queries
  • Maintain oversight of the CAPA process
  • Plan document review processes
  • Train staff in cGxP principles and audit readiness
  • Responsible for the day-to-day management of the site Archive activities
  • Take responsibility for archiving all GxP-related material in an efficient and timely manner and maintaining physical and electronic archive records
  • Ensure documents retained within the Archives are securely stored and easily retrievable in accordance with site and global archiving procedures
  • Oversee the implementation of an electronic archive
  • Manage the RxCelerate biobank and its associated databases

Skills/Requirements

  • A degree in a life sciences discipline and ideally at least 3 years’ experience in a corporate setting
  • RQA certification is desirable
  • An understanding of cGxP regulatory requirements is essential, particularly cGLP and cGCP
  • Experience of interfacing with regulatory bodies, including the MHRA
  • An understanding of the HTA is desirable
  • Experience in auditing GxP studies, processes and facilities
  • Experience of documentation control
  • Archiving experience is desirable
  • Experience of training staff
  • Strong verbal and written communication skills, organisational skills; excellent attention to detail

This is a full-time role, though applicants seeking employment on a part-time basis (3.5–4 days per week) are also encouraged to apply. RxCelerate offers a competitive salary with an annual bonus scheme and company benefit package.

Apply now


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