Compliance Specialist ( Quality ) – Pharma MNC – Mumbai

5 - 8 Years
Mumbai

Job Description

You will be based at a corporate office at Mumbai.
You will be responsible for:
-Ensuring license non-compliances as identified through already established Compliance processes are addressed within a pre-defined time frame based on risk.
-Performing Compliance review of new and revised critical Module 3 documents as compiled by Regulatory, prior to submission.
-Approving Quality Risk Assessments as written by License Compliance team.
-Liaising with Regulatory routinely to ensure submission priorities are aligned and quality critical submissions are prioritised.
-Reviewing and approving critical Module 3 documents written by Regulatory prior to submission to ensure content is CTD compliant.

Required Candidate profile

B.Sc (Chemistry / Microbiology) or M.Sc (Chemistry / Microbiology) with minimum 5 years of experience in Quality Compliance within a Pharmaceutical company.
-You should have extensive GxP knowledge across all dosage forms.
-You should have experience in authoring Module 3 in CTD format.
-You should have extensive knowledge of QMS, specifically change controls and risk assessment, and continuous improvements.

Keyskills

Desired Candidate Profile

Please refer to the Job description above

Education-

UG:B.Sc - Microbiology, Chemistry

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

Doctorate:Doctorate Not Required

Company Profile

HRD House

A reputed pharma company, client of HRD house
View Contact Details+

Recruiter Name:Apeksha

Contact Company:HRD House

Telephone:8879761139

Email :apeksha.hrdhouse@gmail.com,apeksha@hrdhouse.com

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Salary

INR 10,00,000 - 12,00,000 PA.

Role Category

Production/Manufacturing/Maintenance

Role

Quality Assurance/Quality Control Manager

Employment Type

Full Time, Permanent