Job Title: Associate Principal QA Specialist, QA Technical Operations
Client: SRG
Location: Slough, United Kingdom
Job Category: Other
EU work permit required: Yes
Job Views: 4
Posted: 31.05.2025
Expiry Date: 15.07.2025
Job Description:
Role Purpose & Scope
* Support Operations to ensure Compliance to GMP
* Manage and support GMP issues through QMS processes, site governance, and senior QA leadership
* Act as a GMP SME by implementing, managing, and enforcing quality processes on site
* Support Senior QA leadership to drive continuous improvement and maintain compliance with Regulatory Authorities, Global Quality standards, and customer expectations
Key Responsibilities:
* Review, approve, and support management of quality records such as Deviations, CAPA, Change Controls, Investigations, OOS
* Manage and escalate major and critical compliance issues through site QMS processes
* Identify, suggest, and participate in continuous improvement activities
* Mentor and coach business partners in cGMP practices
* Maintain audit readiness
* Participate in PQS process improvement initiatives
* Support manufacturing during out of hours as QA SME
* Perform other duties as assigned
Key Metrics:
Deviation assessments completed within 2 days, among other KPI targets
Key Stakeholders:
* Manufacturing Operations (Cell Banking, Fermentation, Purification, Manufacturing Support)
* Warehouse and Supply Chain
Qualifications:
Minimum requirements include strong decision-making, problem-solving skills, a quality mindset, excellent communication, organizational skills, and relevant GMP knowledge.
#J-18808-Ljbffr