Quality Control job @ Sun Pharma
Job Description
Review of all the instrument calibration documents and ensuring calibrations/Preventive maintenance planned as per the master schedule.
Carryout periodical audits to ensure GMP compliance in day to day analysis.
Familiar in preparation and review of all OOS, OOC and incident-investigation report.
Familiar in trouble shooting of analytical instruments and methods.
Familiar with cGMP requirements and ICH guidelines.
Identify, review and compile deviation and change control.
Preparing and reviewing of method validation and cleaning validation protocols & report, ensure timely preparation of Protocols and reports.
Handle/Resolve all customer concerns related to quality of products and ensure root cause analysis done to avoid recurrence of complaints.
Preparing and reviewing of analytical test reports, COAs, spec and STP, method development reports, weekly update reports and slides presentation.
Performing method development and optimization trials, execution of method verification and validation, method transfer.
Hands on experience on reviewing of analytical data, Empower data, Implementation of GLP and GDP.
Training and provide scientific and technical support to laboratory chemists on laboratory safety, standard operation procedures and instrument operation.
Handling of LIMS. (Laboratory Information Management System)
Hands on experience on development of rugged methods for quantification of low level impurities and genotoxic impurities by GC, GC-MS and HPLC.
Providing continues support from feasibility to scale for new projects in order to facilitate smooth analytical tech transfer with process understanding.
Responsible for Analytical supporting for the end-to-end delivery projects within committed timelines.
Click here to apply
Job Description
Review of all the instrument calibration documents and ensuring calibrations/Preventive maintenance planned as per the master schedule.
Carryout periodical audits to ensure GMP compliance in day to day analysis.
Familiar in preparation and review of all OOS, OOC and incident-investigation report.
Familiar in trouble shooting of analytical instruments and methods.
Familiar with cGMP requirements and ICH guidelines.
Identify, review and compile deviation and change control.
Preparing and reviewing of method validation and cleaning validation protocols & report, ensure timely preparation of Protocols and reports.
Handle/Resolve all customer concerns related to quality of products and ensure root cause analysis done to avoid recurrence of complaints.
Preparing and reviewing of analytical test reports, COAs, spec and STP, method development reports, weekly update reports and slides presentation.
Performing method development and optimization trials, execution of method verification and validation, method transfer.
Hands on experience on reviewing of analytical data, Empower data, Implementation of GLP and GDP.
Training and provide scientific and technical support to laboratory chemists on laboratory safety, standard operation procedures and instrument operation.
Handling of LIMS. (Laboratory Information Management System)
Hands on experience on development of rugged methods for quantification of low level impurities and genotoxic impurities by GC, GC-MS and HPLC.
Providing continues support from feasibility to scale for new projects in order to facilitate smooth analytical tech transfer with process understanding.
Responsible for Analytical supporting for the end-to-end delivery projects within committed timelines.
Click here to apply
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