Pds Qa Project Specialist
Thermo Fisher Scientific seeks a QA Project Specialist to support batch release and regulatory compliance in pharmaceutical manufacturing. The role involves reviewing manufacturing documentation, assessing deviations and customer complaints, and ensuring adherence to GMP and FDA requirements.
Responsibilities
Support Qualified Person in batch release process by reviewing Certificates of Analysis and Batch Manufacturing Records
Perform preliminary assessments of deviations and customer complaints with criticality classification
Review investigation reports and support identification of root causes and corrective actions
Manage customer communication regarding quality issues and participate in customer meetings
Maintain compliance documentation including Standard Operating Procedures, Master Batch Records, and Product Specification Files
Requirements
Bachelor's or Master's degree in pharmaceutical chemistry, pharmacy, chemistry, biology, or related science
Knowledge of pharmaceutical manufacturing processes and controls for clinical and commercial products
Understanding of GMP requirements and FDA regulations
Fluent in English
Strong teamwork, organizational, and communication skills
Effective problem-solving abilities
Responsibilities
Support Qualified Person in batch release process by reviewing Certificates of Analysis and Batch Manufacturing Records
Perform preliminary assessments of deviations and customer complaints with criticality classification
Review investigation reports and support identification of root causes and corrective actions
Manage customer communication regarding quality issues and participate in customer meetings
Maintain compliance documentation including Standard Operating Procedures, Master Batch Records, and Product Specification Files
Requirements
Bachelor's or Master's degree in pharmaceutical chemistry, pharmacy, chemistry, biology, or related science
Knowledge of pharmaceutical manufacturing processes and controls for clinical and commercial products
Understanding of GMP requirements and FDA regulations
Fluent in English
Strong teamwork, organizational, and communication skills
Effective problem-solving abilities