Job Title: Analytical Lab Expert
Overview:
In the Analytical Lab, we are seeking a skilled and detail-oriented expert to join our team as an Analytical Lab Expert. As a key member of our laboratory, you will be responsible for validating analytical methods, conducting cleaning validation, and reviewing data generated by other analysts.
Key Responsibilities:
* Validation of analytical methods and method transfer: Set up and write validation protocols, analyze validation results, provide conclusions, and write validation reports.
* Cleaning Validation: Prepare samples, conduct HPLC analysis, process HPLC data using Empower software, and develop departmental documentation, including lab data sheets, training documentation, SOP's, change controls, deviations, and CAPA ensuring compliance with GMP and regulatory guidelines.
* Annual review (reduced testing program): Analyze data and prepare reports.
* Respond to internal and external enquiries, review data generated by other analysts, and provide technical expertise in pharmacopeia tests, regulatory requirements, changes, and investigations, root cause analysis.
Requirements:
* Master's degree (preferably) or bachelor degree in chemistry/sciences/pharmaceutics or equivalent experience.
* Experience in creating validation protocols, SOP's, and preparing validation reports.
* Knowledge of Pharmacopeias (USP, Ph. Eur., JP) and working knowledge of cGMP requirements.
* Minimum 2 years' experience in an Analytical Lab, experience with HPLC (experience on Waters system), experience in method validation, and knowledge of Empower Software.