Officer / Executive
Company: SUN PHARMA
Job Location: Mumbai, India
Qualification: Bsc, Msc, Mpharm
Experience: 4 to 9 years
Job Profile:
- Hangle Drug Master files of API in CTD and ECTD format, independently iwith the help of plant people.
- Annual updates of DMF and renewal applications for CEP .
- Checking and reviewing of documents required for DMF filing received from plant for its thoroughness and getting corrections done from plant , independently.
- Helping API plants for the preparation of audits from Regulatory Agencies, in case required .
- Handling to DMF deficiencies Preparation of action plan and deficiency responses Timely Response of DMF deficiencies in coordination from R&D, Plant , ADD
- Completion of QA and ISO questionnaire received from customers in coordination with plants.
- Moving to API locations for checking and collection of documents as and when required .
More: http://www.linkedin.com/jobs2/view/9327114?trk=rj_jshp
Company: SUN PHARMA
Job Location: Mumbai, India
Qualification: Bsc, Msc, Mpharm
Experience: 4 to 9 years
Job Profile:
- Hangle Drug Master files of API in CTD and ECTD format, independently iwith the help of plant people.
- Annual updates of DMF and renewal applications for CEP .
- Checking and reviewing of documents required for DMF filing received from plant for its thoroughness and getting corrections done from plant , independently.
- Helping API plants for the preparation of audits from Regulatory Agencies, in case required .
- Handling to DMF deficiencies Preparation of action plan and deficiency responses Timely Response of DMF deficiencies in coordination from R&D, Plant , ADD
- Completion of QA and ISO questionnaire received from customers in coordination with plants.
- Moving to API locations for checking and collection of documents as and when required .
More: http://www.linkedin.com/jobs2/view/9327114?trk=rj_jshp
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