Process Quality Excellence Specialist

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