5 years experience in validation or quality assurance
Strong understanding of ema fda ich regulatory requirements
Proficiency in statistical analysis and data interpretation
The Transport Validation Specialist acts as a Subject Matter Expert ensuring transport validation activities comply with pharmaceutical regulatory requirements
Job Summary
The Transport Validation Specialist acts as a Subject Matter Expert ensuring transport validation activities comply with pharmaceutical regulatory requirements.
Key responsibilities include developing validation protocols, analyzing data for trends, and coordinating with cross-functional teams like quality assurance and supply chain.
The role requires adherence to GMP, GDP, and other industry standards while managing risk assessments and change controls for transport activities.
Matching Summary
The Transport Validation Specialist acts as a Subject Matter Expert ensuring transport validation activities comply with pharmaceutical regulatory requirements.
Skills & Requirements
Must-have
5 years experience in validation or quality assurance
Strong understanding of EMA FDA ICH regulatory requirements
Proficiency in statistical analysis and data interpretation
Knowledge of GMP GDP MDR HACCP regulations
Experience writing and reviewing technical documents
Nice-to-have
Project management skills to manage multiple tasks
Ability to work independently and as part of a team
Excellent written and verbal communication skills
Problem-solving skills to troubleshoot validation issues
Familiarity with IT and automated system validation
Key Requirements
University degree in Engineering or Life Sciences
Minimum 5 years of experience in validation roles
In-depth knowledge of validation principles and practices