Description
Our client, a global Pharma/biopharmaceutical organisation is currently seeking additional support within stability area in preparation for an FDA audit on their leading manufacturing facility in Austria.The responsibilities include:
*Author stability protocols and reports
*Analyze and trend stability data.
*Present and communicate trends to operations and senior management.
*Lead investigations of out of specification and out of trend results.
*Author stability SOPs as required
*Identify and maintain required GMP validation and change control documentation.
*Complies with policies and procedures in order to maintain compliance with legal regulations, health and safety, and regulatory requirements as written
*Owns, develops, and maintains SOPs
*Writes applicable protocols and reports
*Leads method transfers
*Owns/authors deviation and invalid assay assessments
*Performs peer/manager review of data as required
Requirements:
*BS degree in related scientific field
*Must have experience in stability testing
*Knowledge of GMPs, safety regulations and data integrity
*Knowledge of method validation and transfer
*General knowledge of statistical data analysis
This is an exciting opening to work in dynamic team in a short / medium length contract opportunity. Please apply now for more information.