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Quality Specialist/Manager - GXP

Job Title: Quality Specialist/Manager - GXP
Contract Type: Permanent
Location: Wetherby, West Yorkshire
Industry:
Salary: Negotiable
Reference: J894003_1515770658
Contact Name: Tom Hammond
Contact Email: tom.hammond@russell-taylor.co.uk
Job Published: January 12, 2018 15:24

Job Description

QA Specialist/Manager - GXP

Permanent - Harrogate

Our Client - a Global Drug Development company are looking to recruit for an experienced QA / GXP Person to work at their modern complex in Yorkshire.

Responsibilities:

  • Guiding, advising, and influencing the organization on a range of compliance and data integrity matters.
  • Defines, manages, and executes compliance auditing programmes.
  • Fully competent as a Lead Auditor.
  • Trains others in the conduct of external and internal audits.
  • Conducts specialist audits as necessary (multiple GxPs; Data Integrity).
  • Liaises with internal and external parties in order to arrange inspections.
  • Conducts preparation for inspections and briefs audit team as necessary.
  • Ensures appropriate records are generated and maintained for all inspections.
  • Coordinates responses to inspection findings. Ensures findings and responses are recorded in the appropriate system to facilitate tracking.
  • Provides guidance on current regulatory thinking to all levels of the organization.
  • Performs SOP reviews.
  • Ensure knowledge of current regulatory thinking is maintained.
  • Plays an active role in external industry regulatory forums.
  • Active participant in Process Excellence initiatives.
  • Conducts other activities, including GxP audits, as required.

Qualifications/ Experience

  • GXP QA experience essential…
  • Bachelor of Science/Arts (BS/BA) degree (Experience may be substituted for education in some circumstances).
  • Intimate working knowledge of Client SOPs P&Ps as well as local and international GLPs, cGMPs, GCPs and regulatory agency guidelines as applicable.


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