Senior Process Quality Excellence Specialist

4 days ago


Slough, United Kingdom Warman O'Brien Full time

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 GCP experience necessary Willingness to work onsite in Slough 2 days per week Full-time role Competitive hourly rates



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