Validation Specialist Opportunity
The Validation Specialist is responsible for the validation and transfer of analytical methods in accordance with regulatory requirements.
Key Responsibilities:
* Develop and validate established and novel analytical test methods for gene therapy products.
* Generate validation test protocols, data analysis, and reports to support method transfer and validation activities.
* Ensure all methods are validated and transferred to QC labs in compliance with regulatory standards and adhere to data integrity requirements.
Required Skills and Qualifications:
* Bachelor's or Master's degree in human health or sciences.
* 2 years work experience in a regulated industry.
* Demonstrate experience in analytical methods/validation role in research or pharmaceutical industry.
* Proficiency in analytical techniques like qPCR, HPLC, ELISA, and cell-culture.
* Knowledge of ICH Q2 guidelines.
* Proficiency in IT and Microsoft Office software.
Benefits:
* Implementation of test methods to meet site requirements.
* Quality control audits.
* Plan, manage and record training effectively.
Others:
* Identify and resolve problems in a timely manner.
* Look for ways to improve and promote quality.
* Communicate effectively both orally and in writing.
Job Requirements:
* Identify and analyze problems and develop alternative solutions.
* Work under pressure and prioritize tasks efficiently.
* Measure self against standard of excellence.