QA Analyst

• Responsiblties:
• Confirming and ensuring the compliance of the protocols and reports of method validations / verifications / comparison reports and any other study reports.
• Monitoring and ensuring of current Good Laboratory Practices followed by laboratory personnel during routine operation to ensure adherence to procedure.
• Verifying process validation and characterization-related documents.
• Coordinating with the Regulatory Affairs and Analytical Laboratory Teams to arrange required documents for timely submission as part of new and existing abbreviated new drug applications.
• Maintaining all the incoming documents with proper tracking, recording, storage and archival of the documents.
• Reviewing and identifying the gaps within the system during routine monitoring and informing the supervisor for necessary improvements in the identified areas.
• Actively participating in laboratory investigations and incidents as well as ensuring the proper compliance.
• Evaluating and confirming the compliance related to raw materials, inprocess and finished product analytical documents.
• Conducting random internal audits in analytical lab and ensuring the compliance.

Key Skills:

• Introduction.
• Strong Analytical Skills.
• Technical Proficiency.
• Excellent Communication Skills.
• Problem-Solving Abilities.
• Knowledge of Testing Techniques.
• Adaptability and Continuous Learning.