Post : Quality Analyst II
Job Description
Training:
Handling of training related activities as a TSA (Training system administrator) and Coordinating with other departments.
• Conducting cGMP trainings to all employees.
• Responsible to monitor and to ensure the functioning of TrackWise Training Manager at site.
• Responsible for imparting induction training, quality systems training, departmental training and maintenance of training records, Preparation of departmental training schedule.
• Revising/Cancelling/Inactivating a course template for development.
• Creating/Mapping new training requirements to existing curricula.
• Preparation of training trends.
• Preparation of Organogram.
• Coordination of cross functional departments trainings as per training requirements.
• Maintaining the training function audit worthy at all the time.
• Closing of quality assurance training requirements in trackwise.
Job Description
Training:
Handling of training related activities as a TSA (Training system administrator) and Coordinating with other departments.
• Conducting cGMP trainings to all employees.
• Responsible to monitor and to ensure the functioning of TrackWise Training Manager at site.
• Responsible for imparting induction training, quality systems training, departmental training and maintenance of training records, Preparation of departmental training schedule.
• Revising/Cancelling/Inactivating a course template for development.
• Creating/Mapping new training requirements to existing curricula.
• Preparation of training trends.
• Preparation of Organogram.
• Coordination of cross functional departments trainings as per training requirements.
• Maintaining the training function audit worthy at all the time.
• Closing of quality assurance training requirements in trackwise.
Licences Management
• State Licensing Authority (FDA, GOA)
• Coordinate and follow up with local FDA for receipt of licence and addressing the queries initiated by local FDA.
• Complying with conditions mentioned in the test licence and mfg. licence to local FDA
• Drugs Controller General (India) DCGI (New Delhi)
• Coordinate and follow up with DCGI for receipt of licence and addressing the queries initiated by DCGI
• Reconciliation of method transfer and stability samples.
• Complying with conditions mentioned in the test licence to local FDA and zonal offices
• Central Bureau of Narcotics(CBN, Gwalior)
• Coordinate and follow up with CBN for receipt of Narcotic licence and addressing the queries initiated by CBN.
• Reconciliation of imported Narcotic & & Psychotropic Substances samples.
• Complying with conditions mentioned in the test licence to local FDA and zonal offices
• State Licensing Authority (FDA, GOA)
• Coordinate and follow up with local FDA for receipt of licence and addressing the queries initiated by local FDA.
• Complying with conditions mentioned in the test licence and mfg. licence to local FDA
• Drugs Controller General (India) DCGI (New Delhi)
• Coordinate and follow up with DCGI for receipt of licence and addressing the queries initiated by DCGI
• Reconciliation of method transfer and stability samples.
• Complying with conditions mentioned in the test licence to local FDA and zonal offices
• Central Bureau of Narcotics(CBN, Gwalior)
• Coordinate and follow up with CBN for receipt of Narcotic licence and addressing the queries initiated by CBN.
• Reconciliation of imported Narcotic & & Psychotropic Substances samples.
• Complying with conditions mentioned in the test licence to local FDA and zonal offices
Additional Information
Qualification : B.Pharm
Location : Goa
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality
End Date : 20th February, 2019
Qualification : B.Pharm
Location : Goa
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality
End Date : 20th February, 2019
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