Compliance Specialist ( Quality ) – Pharma MNC – 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.
-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.
-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
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.
Industry
Functional Area
Role Category
Production/Manufacturing/Maintenance
Role
Quality Assurance/Quality Control Manager
Employment Type
Full Time, Permanent