Quality and Regulatory Affairs Administrator

Location: Cambridge
Sector: Admin & Customer Service, Temporary & Interim
Job type: Full Time, Temporary
Hours: Monday – Friday 9am – 5pm with 30-minute lunchbreak (37.5 hours per week)
Reward: £Negotiable
Start: ASAP – Urgent Requirement

We are looking for a skilled candidate to join our client’s team on a temporary basis for 3-4 months however for the right person this could lead to a longer-term opportunity in the future. This role will be responsible for assisting in the day to day activities of the Quality department. You will be undertaking tasks that include change control tracking, quality record review, SOP development, process validation, CAPA management and report creation therefore experience within this highly regulated environment is essential.

You will ideally have experience of using QPulse alongside relevant experience that demonstrates your ability to perform in this role. You will hold excellent organisational skills and can work under pressure.

Duties:

  • Assisting in the day to day activities that ensure the Quality department is effective and efficient
  • Change control tracking
  • Quality record review
  • SOP development & Process validation
  • CAPA management and report creation
  • Maintain all Quality modules within the QPulse database
  • Assist in regulatory affair tasks as assigned by the manager
  • Contribute to the creation and reviewal of QMS documentation and records
  • Ensure consistent application and execution of key quality processes
  • Create reports relating to quality metrics and key performance indicators
  • Support internal and external audit activities
  • Coordinate and document the calibration activities of equipment as necessary

Essential Skills/Experience/Education:

  • Experience of working within a highly regulated industry (Pharma or Scientific)
  • Superior organisational skills
  • Ability to work independently under his/her own initiative
  • Excellent aural and written communication skills
  • Ability to work under pressure and to deadlines
  • Experience of QPulse and MSOffice applications
  • Ideally a university degree OR Equivalent experience

If you have not received a response within 3-5 working days, unfortunately your application has been unsuccessful. Busy Bee Recruitment Ltd is acting as an Employment Business for this Temporary vacancy.

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