QA Analyst

2 months ago


Houston, Texas, United States Atechstar Full time

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.
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