Senior Specialist - Extractables & Leachables (18 Months Contract)

gssi.world

E&l risk assessments
Internal standards development
External benchmarking
The job owner acts as primary GSME support for the Medicines Large Molecules & Vaccines division, aligning E&L strategy with R&D for smooth commercial product transfer

Job Summary

  • The job owner acts as primary GSME support for the Medicines Large Molecules & Vaccines division, aligning E&L strategy with R&D for smooth commercial product transfer.
  • Responsibilities include conducting E&L risk assessments, creating/updating internal standards, benchmarking, and advocating GSK's E&L position externally.
  • The role involves working with internal and external laboratories to ensure compliant and cost-effective E&L testing, and interacting with regulatory agencies during audits.

Matching Summary

The job owner acts as primary GSME support for the Medicines Large Molecules & Vaccines division, aligning E&L strategy with R&D for smooth commercial product transfer.

Skills & Requirements

Must-have

  • E&L risk assessments
  • internal standards development
  • external benchmarking
  • regulatory filings support
  • laboratory management
  • Quality Regulatory Intelligence

Nice-to-have

  • interpersonal and communication skills
  • work effectively across diverse customer base
  • teamwork ability
  • problem solving attitude
  • customer focus
  • prioritization skills

Key Requirements

  • 4+ years of experience in E&L, Validation, or Risk Management
  • Regulatory knowledge
  • Strong technical writing skills
  • Benchmarking skills
  • EHS-awareness
  • Proficient in English

Work Rights

Not specified

Tailored Resume

Cover Letter