Quanticate UK - Head Office

QA Manager (GCP)

UK-Hertfordshire-Hitchin | UK-Home Based
1 week ago
ID
2017-1661
# of Openings
1
Category
Quality Assurance

Overview

We are seeking an experienced QA Manager to join our Quality Assurance team. 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 Quanticate and our external clients. You will also work towards deadlines to maintain the Quanticate Quality Management System and CAPA system.

 

Quanticate are passionate about their people and offer a good work/life balance; therefore this role has the flexibility to offer part office (Hitchin) part home based working.

 

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

Qualifications

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

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