Job Description
A global pharma is looking to hire a Process Quality Excellence Specialist on an initial 12 month contract.
Working 2 days per week in Slough, the successful candidate will have the following responsibilities:
* Manage the Regulatory Intelligence Network requirements for the Global Clinical Sciences & Operations group.
* Act as the RIN coordinator and work with the relevant GCSO SMEs for regulatory/guidance requirements to controlled documents as needed.
* 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 studies.
* Act as an Audit Host.
* Work with the Auditing team to host and coordinate with relevant SMEs and functions on any internal Quality Audit.
* You will not be expected to create an audit but act more as a point of contact and co-ordinator with the auditing team.
* During the audit, you will assist the assigned SMEs in responding to queries by the auditees.
* Post-audit, you will work with the SMEs on responses to findings, CAPAs, etc., until the audit is closed.
Preferred Experience:
* 3+ years in the pharmaceutical industry
* Process improvement experience
* RIN or RA experience preferred
* GCP experience needed
* GAP analysis experience preferred
* Audit awareness
* CAPA understanding
* Please note: This is NOT a QA role - my client is not looking for candidates from a QA background.
For a confidential discussion, please get in touch - trish@warmanobrien.com