Website Bajaj Healthcare ltd
Bajaj Healthcare Ltd has an opening for Regulatory affairs Fresher & Experience Job Openings
listed Job Profile.
Department: Regulatory Affairs
Designation: RA – Officer
Education / Qualification: B Pharmacy
Experience: 0 to 1 year
Salary: As per company Standards
- 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.
Application Process : Interested & Eligible Candidates share your Resume to Email ID: email@example.com
To apply for this job email your details to firstname.lastname@example.org