Assistant Manager - Quality Control (stability) Job in Naprod Life Science
Assistant Manager - Quality Control (stability)
Naprod Life Science
4+ weeks ago
- Mumbai, Maharashtra
- Not Disclosed
- Full-time
- Permanent
Job Summary
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
Experience Required :
8 to 12 Years
Vacancy :
2 - 4 Hires
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