Assistant Manager - Quality Control (stability) Job in Naprod Life Science

Roles and Responsibilities :

• Ensure that Stability protocol is approved before charging of stability samples, tracking of stability samples and analysis within defined time intervals.
• Responsible for receipt management and inventory of stability samples
• Responsible for planning and execution analysis of stability samples within defined window frame
• Review the results with previous time points and identify OOT and conduct investigation
• Responsible for review chromatographic data audit trial of computerized QC instrument
• Responsible to maintain the department, equipment and its premises to be clean and to comply cGMP
• Responsible for handling training and its continuation of the planned training as per yearly planner
• Handling QMS a. Deviations, b. Incidents in quality control, c. Change Control, d. Out of Specification, e. out of trend result
• Handling regulatory audits and its compliance
• Responsible to GLP procedure follow, facility and document updating
• Role in LIMS - All QC approvals
• Roles in Master Control - a. Originator of Change control, b. Originator of deviation, c. Originator of incident report, d. Originator of out of specification

Desired Candidate Profile

• 8 to 12 Years of Quality Control Experience in Stability
• Exposure working with liquid injectable
• Experience with Oncology is added advantage