CSV Manager|Join a Fast-growing Mid-sized Pharma Company

Job content

Are you up for an exciting challenge in the pharmaceutical industry? Would like to work as a CSV Manager with a passion for delivering excellence? Our client, a well-established and financially solid company in the pharma sector, is looking for a talented individual like you to join their team and contribute to their ongoing success.

Benefits:

- Be part of a fast-growing mid-sized pharma company, with the opportunity to work on diverse projects and collaborate with different clients and partners worldwide.

- Constant improvement and training opportunities offered to enhance your skills and further advance your career.

- Enjoy the flexibility of remote working, with the option to work from home 2/3 days per week, allowing you to achieve a better work-life balance.

Responsibilities:

• ERP Key User and Core Team Member (incl. Master Data Management) for QA Department
• Responsible for QA-related tasks in relation to data integrity and electronic records management.
• Ensure Software and IT compliance in general (TP QA Corporate), among others: Excel spreadsheet validation, computerized system validation, supplier (re)qualification for computerized systems and services
• Responsible for QA-related tasks for IT Changes and for Serialisation/TES
• Review and approval of computerized system validation in general
• Represent QA in CSV-related projects
• Supervision of QA relevant issues/processes and support with focus on GxP-related computerized systems, IT, ERP, and Serialisation/TES
• Coordination of quality relevant relations with suppliers and customers (deviations, CAPA, changes)
• Manage and maintain the revision/compilation of quality documents (e.g. SOPs)
• Review of batch documentation / perform shipment release
• Completion of internal and external audits

Requirements:

• Minimum bachelor’s degree in a life science-related discipline.
• A proven track record of at least 5 years of experience in Computerized Systems Validation (CSV), demonstrating a strong understanding of regulatory requirements.
• Excellent knowledge and understanding of GMP, including 21 CFR Part 11 and EU GMP Guide Annex 11, as well as GAMP5 guidelines.
• Good knowledge of QA Compliance, capable of handling compliance-related challenges.
• Fluency in both written and spoken English and German.
• A flexible and structured team player with the ability to work in a fast-paced, rapidly changing environment and a problem-solving approach.

Send your CV now! We will reach out to you in case you match the requirements of the role.

You can contact me via: a.andreenkova@nonstop-recruitment.com

Do you have any disability or condition that could affect you in the application and interview process? Please feel free to share this information as part of your application, including any necessary adjustments you might need, so we can help make the process easier for you. We assure you this information will not have any negative effect on the interview process outcome.

About NonStop: We are NonStop, a leading provider of staffing solutions throughout Europe and now also in the US. We’re passionate about connecting talent with opportunity and work non-stop to support our clients in hiring the best talent for their teams. Feel free to pop over to our website, NonStop Consulting, for more information, to browse all our roles, or to let us know how we can help you.