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| Job Location | Mumbai City |
| Education | Not Mentioned |
| Salary | Rs 1.5 - 3.0 Lakh/Yr |
| Industry | Medical / Healthcare |
| Functional Area | Audit |
| EmploymentType | Full-time |
- Experience of handling team of RA officers, and responsible for follow up the requirementsdata, getting it completed within timelines by effective communication, with crossfunctional teams & visiting manufacturing facility, if required.- Tracking of activities status to meet timelines of responses, DMF submissions.- Should have Knowledge & clarity for accurate responses of technical requirements- Experience of preparation & review of various region submissions, deficiencies responses(US, Europe, Japan, ROW), & Knowledge of E-CTD Submissions- Conversant with current Guidelines, Regulations, QA documentation, Change controls,Change management, OOS, deviations etc.- Paying of GDUFA Site, DMF fees to various Health Agencies, Drug Listing- Reviewing Analytical Method Validations, Process validations & analytical data,manufacturing site data.- Computer proficiency.- Customer Support:Should know all aspects of Customer requirements documents & able to provide timelysupport, tracking activities- Reviewing / Answering queries of Authorities/Customers,- Control over timely documentation activities, supporting Life Cycle Management.
Keyskills :
process capabilityregulatory affairsproduct qualitysupplier qualitytotal quality managementiso 9000isoaudit compliancepdca cycle