Develop and manage all validation activities under the Quality Management System
Provide expert advice on the validation strategy for development programs
Develop and maintain the Validation Master Plan (VMP)
Develop systems, processes, tools and templates for the conduct of qualification and validation activities
Work cross functionally to develop qualification and validation protocols in accordance with the requirements of the VMP
Review and approve qualification and validation reports
Project Management of validation activities
Initiate and manage deviations, changes and risk assessments in the conduct of validation activities
Quality oversight of the stability program
Quality oversight and support for technical transfer activities
Support the ongoing continuous improvement of the company’s QMS in compliance with applicable GxP requirements and regulatory guidelines
Lead by example in promoting and facilitating a quality culture
Provide training to staff on quality topics
Support the conduct of quality investigations and initiatives
Prepare, manage and present materials for Quality Management Review

At least 5 years of hands-on experience of validation in a GMP sterile manufacturing environment, ideally in a development setting
Strong understanding of and experience of GMP requirements in the EU and US and sound knowledge of applicable ICH guidelines
Demonstrated expertise in the management of validation activities
Experience of method validation, process validation and equipment qualification
Experience of Computer System validation is an advantage
Excellent problem-solving, analytical, and communication skills
Familiarity with electronic Quality Management Systems (eQMS)
Fluent in English

Attractive compensation package, including a competitive base salary and stock options
30 vacation days
Flexible working hours
Annual health budget (Allianz bKV)
EGYM Wellpass
Relocation support

Validation Manager, Pharmatech Industry

Key skills