Role overview

Responsibilities

Developing and ensuring compliance with quality plans and programs
Coordinating regulatory inspections under the manufacturing and wholesale distribution licenses
Implementing regulatory compliance in cooperation with the Regulatory Affairs Manager
Monitoring of Group quality standards and their implementation in the local QMS
Recording and initial assessment of reported cases of drug risks or suspected cases where pharmaceutical-technical defects are involved
Collaboration and point of contact for Customer Service/KAMs/Medical Information and other departments regarding complaints

Key facts

Remote from: India
Full time
Quality Assurance Specialist
English

Hard skills

Regulatory Compliance Risk Analysis

Other skills

Customer Service
Collaboration
Communication
Problem Solving
Teamwork

About the company

Zentiva

Pharmaceuticals

Company details

Company typeLarge

IndustryPharmaceuticals

Links

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Job description

· Developing and ensuring compliance with quality plans and programs

· Coordinating regulatory inspections under the manufacturing and wholesale distribution licenses

· Implementing regulatory compliance in cooperation with the Regulatory Affairs Manager

· Monitoring of Group quality standards and their implementation in the local QMS

· Recording and initial assessment of reported cases of drug risks or suspected cases where pharmaceutical-technical defects are involved

· Collaboration and point of contact for Customer Service/KAMs/Medical Information and other departments regarding complaints.

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