Asst. Manager / Manager – QA ( API Manufacturing )

5 - 9 Years
Kolkata

Job Description

* Data integrity checking & Periodic review of electronic system in QC instrument and software.
* Electronic data review for analytical data packages
* Change Control review and assessment.
* Compilation of stability report and review of stability study protocol.
* Review of QC analytical records of raw material,Intermediates and Final APL
* Release and rejection of RM,Intermediate & Finished goods products through LIMS.

Keyskills

Desired Candidate Profile

* Performing Product Quality review and preparation of review report
* Review of qualification and analytical method validation documents
* Manufacturing clearance before batch start up for US marketed intermediates and API
* Performing of GMP monitoring at manufacturing facilities
* Performing of IPQA monitoring during validation batches in manufacturing area
* Performing of self inspection and vendor audit as per schedule

Education-

UG:B.Pharma - Pharmacy, B.Sc - Chemistry

PG:M.Pharma - Pharmacy, 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 10,00,000 - 15,00,000 P.A.

Industry

Pharma / Biotech / Clinical Research

Functional Area

Production, Manufacturing, Maintenance

Role Category

Production/Manufacturing/Maintenance

Role

Quality Assurance/Quality Control Manager

Employment Type

Permanent Job, Full Time