Expert in Drug Gxp and Quality Control - Centerville, KS, United States - SilverLinx

SilverLinx

Verified Company

Centerville, KS, United States

3 weeks ago

Posted by:

James Miller

beBee Recruiter

Freelance

Description

As a (Junior) Expert in Drug GxP & Quality Control, you will support the legal functions, particularly the management of manufacturing and the Qualified Person, in all administrative and operational tasks.

In this role, you will contribute to ensuring that pharmaceuticals or other products assigned to the Drug GxP & Quality Control department comply with legal requirements, standards, and internal guidelines.

This position is a maternity leave replacement and is limited until December 31, 2024.

Your tasks:

Coordination and coordination of tasks and issues related to the contract manufacturing of pharmaceuticals as the interface to contract manufacturers (contact person for contract manufacturers)
Coordination and coordination in planning and conducting validations
Creation, review, and documentation of printed labeling materials for products
Maintenance and support in maintaining quality assurance agreements, with a focus on contract manufacturing
Monitoring of qualityrelated changes within the scope of change control
Participation and regular review and adaptation of the pharmaceutical quality management system to the latest state of knowledge
Preparation, implementation, and updating of employee training on pharmaceutical law or qualityrelated issues (e.g. SOPs)
Evaluation and implementation of product changes or variations, including updating the marketing authorization dossier with regard to CTD, Module 3 (quality)

Your profile:

Completed degree in pharmacy or a comparable university degree
First professional experience in the manufacturing and/or testing of pharmaceuticals gained through internships or student jobs
Expertise