Sr. Officer / Executive – RA ( API Manufacturing )

5 - 8 Years
Kolkata

Job Description

* Regulatory filing of new products
* Life cycle management of existing products
* Regulatory review of Module
* Routine regulatory support to plant activities
* Review and preparation of SOP and related documents as per regulatory submission requirement

Keyskills

Desired Candidate Profile

* Review of specification,test procedure,analytical validation,and process development report during development activities
* Periodic discussion with team on regulatory updates/guidance
* To support department as training coordinator and by ensuring compliance with plant and external SOPs
* Adherence to EHS system and procedures.

Education-

UG:B.Sc - Chemistry

PG:MS/M.Sc(Science) - Chemistry

Company Profile

Crown HR Services

Company is a public company primarily operating in the field of Research & Development and manufacturing of world-class oncology drugs.
View Contact Details+

Recruiter Name:Nagma Dash

Contact Company:Crown HR Services

Telephone:7820082233

Website:http://www.crownhrservices.com

Salary

INR 3,00,000 - 6,00,000 P.A.

Industry

Pharma / Biotech / Clinical Research

Functional Area

Production, Manufacturing, Maintenance

Role Category

Production/Manufacturing/Maintenance

Role

Quality Assurance/Quality Control Executive

Employment Type

Permanent Job, Full Time