Deputy ManagerManager - QC
Deputy ManagerManager - QC
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- Handling and Monitoring of all QC related activities as a QC department Head.
- Handling and Monitoring of internal External and regulatory audits and Audits related observation responses and CAPA implementation.
- Monitoring the in process Intermediate API Raw material Stability and GLP Sections.
- Monitoring the API sampling plan Analysis and Release activities.
- Monitoring the Raw material samples sampling and analysis planning review and approval of the Raw materials. Key raw material vendor qualifications.
- Working standards and inhouse reference standards qualification planning as per schedule.
- Working standard qualifications against with pharmacopeial standards.
- Working standard COAS preparation & approvals.
- Standards consumption & Destruction records maintaining.
- Analytical instruments/equipment s qualifications. (URS SAT FAT DQ IQ OQ PQ)
- Coordination with external vendor for instrument/equipment qualifications.
- Preparation of Preventive maintenance Internal calibration &External calibration schedules as per the Quality control procedures.
- Analytical instruments calibration planning as per schedule dates.
- Software qualifications as per GAMP5.
- Planning of stability samples initiation protocols preparation review and approval.
- To plan the stability samples analysis summary reports preparation.
- Stability chambers management and monitoring the mean kinetic temperature.
analytical instruments qualification,stability testing,maintenance,analytical instruments,quality control,external audits,capa implementation,calibration,regulatory compliance,internal audits,gmp standards,software qualification (gamp5,api sampling,raw material analysis
Employment Type
Full Time
