QA Batch Release Sr. Associate

Job Description:

Responsibilities

• Evaluate and review commercial drug batches to ensure compliance with established specifications. 
• Conduct rigorous sampling and statistical process control procedures to identify deviations from standards. 
• Approve investigations and change control activities to maintain compliance with configuration management policies. 
• Contribute to moderately complex projects, managing time effectively and developing short-term work plans. 
• Independently assess Change Control activities for potential Quality and Operational Good Manufacturing Practices (cGMP) impacts. 
• Investigate and document Quality Assurance deviations, escalating issues to the Quality Assurance Lead as needed. 
• Ensure regulatory compliance with current Good Manufacturing Practices (GxP) and provide Quality Review and oversight of site documentation to meet global regulatory and Pfizer quality standards. 

Qualification & Experience

• Bachelor of Sciences/ Pharmacy with 8+ years of experience or Masters degree with 6+ years of experience with relevant experience in Manufacturing upstream/ downstream operations. 
• Solid understanding of current Good Manufacturing Practices and relevant GxP regulations and standards
• Strong critical thinking skills
• Ability to work effectively within own team and interdepartmental teams
• Good working knowledge of Microsoft Excel and Word
• Proactive approach to problem-solving