Process Quality Excellence Specialist
Posted 5 days ago by Warman O'Brien
Negotiable
Undetermined
Hybrid
Slough, England, United Kingdom
Summary: The Process Quality Excellence Specialist role at a global pharmaceutical company involves managing regulatory intelligence requirements and coordinating with subject matter experts (SMEs) for controlled documents. The position includes acting as a point of contact during internal quality audits and assisting SMEs in responding to audit queries and findings. This is a non-QA role, focusing on process improvement and regulatory compliance within the clinical sciences and operations group.
Key Responsibilities:
- Manage the Regulatory Intelligence Network requirements for the Global Clinical Sciences & Operations group.
- Act as the RIN coordinator and collaborate with relevant GCSO SMEs for regulatory/guidance requirements.
- Review regulations and assign SMEs based on the topic.
- Confirm that CROs have assessed regulatory and country regulations impacting their SOPs and studies.
- Act as an Audit Host and coordinate with the auditing team and relevant SMEs during internal quality audits.
- Assist assigned SMEs in responding to queries during audits and work on responses to findings and CAPAs post-audit.
Key Skills:
- 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.
Salary (Rate): undetermined
City: Slough
Country: United Kingdom
Working Arrangements: hybrid
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
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