Post : Quality Analyst III
Job Description
• Preparation of Test Licence and Mfg. Licence, additional Bulk Pack or Blister pack application etc.
• Coordinate and follow up with local FDA for receipt of licence and addressing the queries initiated by Local FDA.
• Preparation of test license NOC for new drugs application.
• Complying any condition mentioned in the import licence and the NOC to DCGI
• Preparation of Import licence for stability and method transfer samples.
• Preparation of test license NOC for new drugs application.
• Complying any condition mentioned in the import licence
• Preparation of application for import & export licence for Narcotic & Psychotropic Substances.
• Complying any condition mentioned in the Narcotic licence
• DATA INTEGRITY COMPLIANCE :
• Handling of training related activities as a TSA (Training system administrator) and Coordinating with other departments
• cGMP trainings to all employees.
• Maintenance of the training records of the employees.
• Responsible for imparting induction training, quality systems training, departmental training and maintenance of training records, Preparation of departmental training schedule.
• Responsible to monitor and to ensure the functioning of Trackwise Training manager at Site.
Job Description
• Preparation of Test Licence and Mfg. Licence, additional Bulk Pack or Blister pack application etc.
• Coordinate and follow up with local FDA for receipt of licence and addressing the queries initiated by Local FDA.
• Preparation of test license NOC for new drugs application.
• Complying any condition mentioned in the import licence and the NOC to DCGI
• Preparation of Import licence for stability and method transfer samples.
• Preparation of test license NOC for new drugs application.
• Complying any condition mentioned in the import licence
• Preparation of application for import & export licence for Narcotic & Psychotropic Substances.
• Complying any condition mentioned in the Narcotic licence
• DATA INTEGRITY COMPLIANCE :
• Handling of training related activities as a TSA (Training system administrator) and Coordinating with other departments
• cGMP trainings to all employees.
• Maintenance of the training records of the employees.
• Responsible for imparting induction training, quality systems training, departmental training and maintenance of training records, Preparation of departmental training schedule.
• Responsible to monitor and to ensure the functioning of Trackwise Training manager at Site.
Candidate Profile
BSc/B Pharm with 9 to 12 years
BSc/B Pharm with 9 to 12 years
Additional Information
Qualification : B.Pharm, B.Sc
Experience : 9 to 12 years
Location : Goa
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality
End Date : 28th February, 2019
Qualification : B.Pharm, B.Sc
Experience : 9 to 12 years
Location : Goa
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality
End Date : 28th February, 2019
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