Job Description
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