Ra - Officer

6 days ago

Thane, India Bajaj Healthcare Full time

**Department**: Regulatory Affairs

**Designation**: RA - Officer

**Education / Qualification** : B. Pharm

**Experience**: 0 to 1 year

**Salary**: As per company Standards

**Responsibilities**:

- Registering our manufacturing site in Sedex platform, completing Responsible Sourcing Policy and initiating for Smeta 4 pillar Audit from 3rd party Audit Agency.
- Quality Management System Audit Preparation (ISO 9001: 2015)
- Preparing company and API (product) presentation.
- Data compilation and Preparation of Drug Master File (DMF) related to other countries as per marketing department requirement.
- Preparing Technical Packages for existing/prospective customer for initial assessment of the API.
- Making responses to Customer queries.
- Drafting Letter of access to existing Drug Master Files and declarations/notifications for regulatory submissions and customers & Marketing department.
- Review of Analytical method validation, Process Validation, Checking BMR documents for DMF filings.
- Drafting and submission of Technical Information packages of New Active Pharmaceutical Ingredients for customers.
- Drafting and Reviewing of Drug Master Files/Technical Package Applicants Parts of Key starting materials.
- Extracting information required from various departments (R&D, QC, QA & Production) within the organization for responding to the market complaints/ queries of customers.
- Necessary assessment of outsourced intermediates/Starting materials of APIs.
- Plant visit w.r.t. documents checking and different Agenda.
- Preparing & Reviewing regulatory documents to support ongoing regulatory requirement.
- Arranging & dispatching the samples to customers for business development.
- To share filled Vendor questionnaire and supporting attachments required for qualification and approval.
- To carry out Vendor assessment for the Key starting materials; Raw material, solvents, reagents which are procured on Domestic level as well as which are Imported.
- To collect samples from respective manufacturing unit and arranging analysis of the same in outside laboratories for various test parameters.
- Arranging reference/ impurity standards to respective manufacturing unit for qualification.
- Preparing SDS in compliance with REACH and GHS label requirements.

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