For their Mannheim-based branch our client is looking for a European QA Validation Lead.
Responsibilities
- Developing of strategic initiatives on a global scale and putting them to work to provide for the execution of New Product Introduction PPQs - Cooperation with partners as for instance Global and Site Operations and QA, Research & Development and Science & Technology in order to encourage a broader efficiency in the network - Inspecting and approving of Project Validation Plans linked with New Product Introductions as well as making sure that validation protocols and final reports connected with New Product Introductions are in accordance with the cGMP standard - Supervision, inspection and authorization of validation change control processes in all sites with New Product Introductions - Managing of process improvement initiatives as determined while developing and overseeing indicators of validation execution performance - Establishment of litigable resolution plans
Requirements
- Completed studies in engineering or a scientific discipline - At least 10 years of experience in an environment regulated by cGMP - Successfully demonstrated validation activities - Innovative thinking in situations in which new and untested solutions are being proposed and put into work regularly - Problem solving skills and adaptability to new requirements - Ambitious to reach results, and meet targets and standards - Verbal and written communication skills of the highest level - Strong interpersonal skills - Determination of validation requirements and the development of plans for the delivery all over the network - Making sure that all procedures and regulations are taken into account - Global SME in all issues of Process Validation and able to provide direction in this field - Collaboration with key stakeholders - Taking on technical leadership within the company's network - Responsibility for technical data presentations to stakeholders and making sure decisions are made timely.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Kimberly Schaperklaus.