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Senior Process Quality Excellence Specialist

2 weeks ago

Slough, Slough, United Kingdom Warman O'Brien Full time £60,000 - £120,000 per year

A global pharmaceutical company is looking to hire a Senior Process Quality Excellence Specialist on an initial 12 month contract. Working on global study specific activities within a growing team, you will have the following responsibilities:

  • Become the Regulatory Intelligence coordinator to work with the relevant SMEs for regulatory/guidance requirements to controlled documents
  • Review regulations and identify which SMEs should be assigned based on the topic
  • Act as a point of contact to confirm that CROs have assessed regulatory and country regulations that may impact their SOPs and clinical studies
  • Act as Audit Host - work with the Auditing team to host and coordinate with relevant SMEs and functions on any internal Quality Audit
  • Act as a point of contact and co-ordinator with the auditing team
  • During the audit, assist the assigned SMEs in responding to queries by the auditees. Post-audit, work with the SMEs on responses to findings, CAPAs, etc., until the audit is closed.

Additional information:

  • Regulatory Intelligence experience required
  • QA or Clinical Operations background preferred
  • Willingness to work onsite in Slough 2 days per week
  • Full-time role
  • Competitive hourly rates