Preparation of Dossiers namely CTD ( Common Technical Dossier) and ACTD (Asian Common Technical Dossier), eCTD (Electronic Common Technical Dossier)
Reviewing documents received from QA/QC & maintaining records
Printing & Filing of dossier & data
Co-ordinating with the production & packing for samples
Arranging & checking art-works of products for registration
Searching guidelines of registration for different countries such as ROW Guidelines and guidelines for CTD (Knowledge of Modules -1,2,3,4,5)
Handling queries & deficiencies for submitted products
Arranging working standard for analysis
Arranging impurities for registration purpose
Reviewing of documents received from public labs
Preparation of data like Stability, Specification & Standard Test Methods, Standard Operating Procedure, Certificate of Analysis.
Visiting Mfg. Plant for the data required for submission
Checking MFR & BMR for correct calculations
Insisting QA / QC for periodic updates in the documents
Arranging DMF of API from API Manufacturer
Co-ordinate with Licensing department for COPP (Certificate of Pharmaceutical Products)applications
Maintaining Product registration status for all countries (country wise / person wise)
Required Skill:
Exposure to Pharma Companies/Formulation dept./Production/QC/QA Depts
Proper understanding of Pharmaceutics and Pharmacology
Technically Comprehensive
Fine Analytical Skills
Systematic approach
Proactive approach to problem solving
Candidate should not be egoistic, but should be soft spoken, candid & blend easily
Thorough Knowledge of GMP Practices
Engrossment in job related work-enjoying his/her work
Good computation Skills
Strong and consistent
Logical Interpretation of Data
Ability of multi-tasking
An eye for detail
Ability to train and lead the team
Eligibility Criteria:
B. Pharm Experience of 2-5 Years
Candidates basically from Mumbai & suburban origin are preferred
Computer Efficacy in MS-Office and Internet
Eligibility Criteria:
Regulatory Affairs
ROW & Regulatory Market
careers@blissgvs.com
Reviewing documents received from QA/QC & maintaining records
Printing & Filing of dossier & data
Co-ordinating with the production & packing for samples
Arranging & checking art-works of products for registration
Searching guidelines of registration for different countries such as ROW Guidelines and guidelines for CTD (Knowledge of Modules -1,2,3,4,5)
Handling queries & deficiencies for submitted products
Arranging working standard for analysis
Arranging impurities for registration purpose
Reviewing of documents received from public labs
Preparation of data like Stability, Specification & Standard Test Methods, Standard Operating Procedure, Certificate of Analysis.
Visiting Mfg. Plant for the data required for submission
Checking MFR & BMR for correct calculations
Insisting QA / QC for periodic updates in the documents
Arranging DMF of API from API Manufacturer
Co-ordinate with Licensing department for COPP (Certificate of Pharmaceutical Products)applications
Maintaining Product registration status for all countries (country wise / person wise)
Required Skill:
Exposure to Pharma Companies/Formulation dept./Production/QC/QA Depts
Proper understanding of Pharmaceutics and Pharmacology
Technically Comprehensive
Fine Analytical Skills
Systematic approach
Proactive approach to problem solving
Candidate should not be egoistic, but should be soft spoken, candid & blend easily
Thorough Knowledge of GMP Practices
Engrossment in job related work-enjoying his/her work
Good computation Skills
Strong and consistent
Logical Interpretation of Data
Ability of multi-tasking
An eye for detail
Ability to train and lead the team
Eligibility Criteria:
B. Pharm Experience of 2-5 Years
Candidates basically from Mumbai & suburban origin are preferred
Computer Efficacy in MS-Office and Internet
Eligibility Criteria:
Regulatory Affairs
ROW & Regulatory Market
careers@blissgvs.com
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