MS&T Specialist

Job Description

Our client, a multinational pharmaceutical company specializing in generics, is seeking a MS&T Specialist for a 1-year contract in Davie, FL.

Responsibilities :

• Performing activities related to critical aspects of products and processes, including process development, pre-validation and optimization of solid oral dosage forms after Abbreviated New Drug Application (ANDA) filing throughout product launch and commercial lifecycle including process, cleaning and packaging validation. Executes studies with Research and Development (R & D), Laboratory Technical Services (LTS), manufacturing and planning.
• Maintains expertise related to formulation, raw material properties and manufacturing processes. Identifies, analyzes and suggests corrective actions to optimize procedures, processes, materials, technology and regulatory compliance issues.
• Digital literacy including basic knowledge of AI (working knowledge of PowerBI, Power Platform, Python and various presentation tools), JMP, R, etc. is necessary.
• Performing investigations to identify the root causes and actively seek remediation approaches and implement Corrective and Preventive Actions (CAPAs).
• Review and analysis of the analytical and statistical data to support the pre-validation work. Analysis of data to ascertain the data meets protocol and product acceptance criteria, writes deviation reports and technical assessments as required.
• Participation in internal (Corporate and QA audits) and external (FDA, MHRA) audits.

Education :

Skills :