Job Title: ZTMP QA of QC
Location: Manufacturing - API, Ankleshwar, Gujarat, India
Posted: Feb. 12, 2025
Employee Type: C-C8-Confirmed-HO Executive
Experience Range: Minimum 4 years
Preferred Background: Quality Control
Job Responsibilities:
Ensure Good Laboratory Practices (GLP) and compliance with QC SOP.
Review and approve analytical reports for intermediates, drug substances, stability reports, stability protocols, trends, and instrument calibration.
Review and approve stability and API analytical reports.
Review and approve working, reference standards, and certificates of analysis (COA).
Handle the issuance and retrieval of controlled documents related to QC.
Review audit trails in laboratory software.
Review user access privileges of instruments and ensure compliance.
Coordinate and provide documents for Drug Master File (DMF) filings.
Review specifications and standard testing procedures.
Oversee the calibration of laboratory instruments and equipment.
Participate in technology transfer and related activities.
Review stability summary trends and risk assessment reports.
Requirements:
Total Experience: Minimum of 4 years
Preferred Background: Experience in the Quality Control department.
Key Skills: Knowledge of GLP, QC SOP compliance, analytical reports, stability protocols, calibration processes, and DMF filings.
This position offers an opportunity to work in a critical quality assurance role in a regulated manufacturing environment, ensuring compliance and the integrity of laboratory processes.
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