Senior QC Validation Engineer - Analytical Methods \& GMP Compliance
Core
Lead analytical method validation, transfer, verification, and lifecycle management within a QC Chemistry Laboratory to ensure quality and compliance of medicines.
Role type
Senior IC QC Validation Engineer (Analytical Methods)
Builds
Validated analytical methods and quality documentation for pharmaceutical manufacturing
Domain
Pharmaceutical manufacturing / Analytical Chemistry
Required skills
Analytical method development, method validation, method transfer, lifecycle management, change control, deviation handling, CAPA processes, pharmacopeia updates (USP, Ph. Eur.), regulatory guideline knowledge (ICH Q2, ICH Q14, EU GMP Annex 1), SOP/protocol/report authoring, external lab collaboration, audit representation
Preferred skills
Knowledge of ICH Q2 (R2), ICH Q14, EU GMP Annex 1, experience in biotechnology, life sciences, or diagnostics
Technologies
USP, Ph. Eur., ICH Q2 (R2), ICH Q14, EU GMP Annex 1
Responsibilities
Lead method transfer, validation, verification and implementation; Author, review and approve analytical methods and documentation; Collaborate with external laboratories; Prepare and approve key quality documentation; Ensure timely implementation of pharmacopeia updates; Execute change control and handle deviations; Represent the department in audits
Seniority
Senior, hands-on IC
