Description

 Specific Duties:  

• Supports and leads the design, development, and qualification/validation of analytical methods intended to assess critical quality attributes of raw materials, drug substances, intermediates, and products. 
• Ensure evaluation and testing of GBI products are performed in accordance with regulatory standards, and scientific best practices and are completed on schedule. 
• Participate in developing and managing stability program. 
• Responsible for generating/reviewing Stability Protocols per ICH guidelines and generating the Summary Reports
• Review, write and supervise the execution of the input and output reports and SOPs
• Ensure all the exception documents are closed on time.
• Ensure all analytical raw data are reviewed and finalized on time. 
• Oversee /Mentor compliance specialist /Data reviewer to review the documents in compliance . 
• Participates in client audits and in other regulatory inspections, and meetings as required. 
• Monitor laboratory notebooks to ensure issuance, review, and archival are conducted in a timely manner in accordance with established standards.

Requirements

Education: Bachelor in biological or biochemical sciences or related field.

Experience: Must have at least five years of direct work experience in FDA regulated environment. 

Skills:

• The candidate will be a problem-solver with the ability to exercise sound judgment under challenging circumstances. 
• Excellent written and verbal communication skills with the ability to effectively promote intra-and inter-departmental cooperation. 
• Knowledge of GMP, ICH, and compendial requirements and their application. 
• Strong attention to detail, observation, organizational, and leadership skills. 
• Possess strong character with self-confidence and integrity.
• Time Management skills 
• Conflict Resolution. 
• Critical Thinking. 
• Priority Management. 
• Diversity Awareness.