Quality Associate (electronic Systems Team)

Catalent is currently recruiting for a Quality Associate to join the Swindon site. This is a role based within the Quality (QMS) department, working in the Electronic Systems team. The team have the responsibility for the management and compliance for a number of site Electronic Systems including MES, GLIMS, Trackwise, Compliance Wire. The team are responsible for the management of the sites Data Integrity programme and compliance.

The Candidate:

• To perform an Administration management role for Electronic Systems within Quality, including Compliance Wire, Global Trackwise and GLIMS.



• User administration


• Provision for system support


• General guidance and enquiries from site users.


• Working closely with sitewide department representatives.


• Customer liaison where required.


• To become part of the site LIMS management team.


• To perform Data Integrity assessments and conduct periodic User Review and Audit Trail review for laboratory and other site systems.


• Assist in implementation projects for new Quality Systems.


• To act as trainer and subject matter expert (SME) in defined quality systems.


• To provide support during regulatory and customer audits.


• Act as owner of change controls and change control tasks relevant to the QMS team, and to act as Quality reviewer for site change controls.


• Ownership of projects relating to the Quality department and participation in site improvement projects.


• To comply with Company Health and Safety requirements and initiatives.


• To provide support to the wider QMS and Compliance Teams.
  
  Experience working within a GMP or another regulated environment.


• Experience of laboratory instrumentation & computer systems or IT systems would be an advantage.


• Experience of working with electronic data systems.


• Knowledge of data integrity requirements in a regulated environment.


• Excellent attention to detail.


• Excellent communication skills.


• Must be a team player and act with honesty & integrity.
  
  Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.


Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone\xe2\x80\x99s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.