"Bajaj Healthcare Ltd" has an opening for listed For fresher B. Pharm (0-1 year) 

Department: Regulatory Affairs Designation RA - Officer

Education / Qualification: B. Pharm Experience: 0 to 1 year 

Salary: As per company Standards 

Email ID: hrd@bajajhealth.com Job 

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. 

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