Quality Assurance Manager

Recruiter
Vivid Resourcing Ltd
Location
Cambridge
Salary
Competitive
Posted
16 Feb 2018
Closes
20 Feb 2018
Contract Type
Permanent
Hours
Full Time

Overview:

With your excellent organizational skills and eye for detail you will be confident in planning, conducting, and reporting on internal audits, and facilitating external audits. As a customer focused business you will liaise and build close relationships with departments across the company. You will also work towards deadlines to maintain the Quality Management System and CAPA system.

- Flexible working available - part home based

Responsibilities:

  • Plan, manage, conduct, and report internal system audits/critical supplier audits

  • Ensure project team members are kept up to date on current regulatory guidelines and procedures

  • Manage client audits, both pre-study and active study audits of Quanticate operations

  • Maintain the QA database

  • Manage continuous improvement based on audit/inspection observations and CAPAs

  • Host ISO (ISO 9001/ISO 27001) accreditation audits

Requirements:

  • Experience in Quality Assurance and GCP (good clinical practice) auditing

  • Clinical Data management experience
  • A relevant degree or demonstrable equivalent professional experience

  • Previous pharmaceutical industry experience would be of benefit

  • Excellent communication skills (oral and written English)

  • Organised and able to meet deadlines

  • Able to plan and prioritise work appropriately

  • Good analytical skills

  • Good administrative skills

  • Flexible and able to work under pressure

  • Ability to build rapport quickly and gain credibility with all levels of the organisation

  • Confident and proficient in using Microsoft Office

  • Excellent document presentation skills

  • Excellent eye for detail

  • The ability to work independently and take initiative

  • Approachable, friendly, confidential, and trustworthy

  • Good negotiation and supervisory skills

Vivid Resourcing are committed to equality of opportunity for all applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships or any other characteristic protected by law.