European QA Validation Lead
Location: GermanySIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical organisation, based in Baden-Württemberg Germany.
- 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
- 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.
The Company
Our client is a renown biopharmaceutical company.Role Description
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.
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