Bajaj Healthcare Ltd Hiring for Regulatory Affairs - Daily Pharma Jobs

Bajaj Healthcare Ltd Hiring for Regulatory Affairs

“Bajaj Healthcare Ltd” has an opening for listed Job Profile.
Department : Regulatory Affairs
Designation : RA – Officer
Education / Qualification : B. Pharm
Experience : 0 to 1 year
Salary : As per company Standards
Email ID : [email protected]
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.
·       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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