Job
In this role, you will test software changes according to internal standards, prepare test data, document deviations, and manage the validation of new tools and modules in a regulated environment.
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Your role in the team
- Functionally test software changes based on internal standards.
- Derive test cases from requirements (URS) and risk analyses, prepare test data, document deviations, and track them through to resolution.
- Reproduce issues observed in production and prepare them for the development team.
- Initial validation and revalidation of new tools and functions requiring validation.
- Validation upon the introduction of new modules, after updates and configuration changes, as well as periodic reviews.
- Assess change control processes from a validation perspective.
- Review data integrity (ALCOA+), audit trails, and access and role concepts.
- Design and deliver training on computer-based systems upon their introduction and following relevant changes.
Our expectations of you
Education
- Completed degree or vocational training in computer science, automation engineering, software development, or a comparable qualification.
Qualifications
- Knowledge of EU GMP Annex 11, GAMP 5, and Data Integrity (ALCOA+); basic knowledge of EU GDP.
- Very precise, traceable documentation.
- Strong teaching skills and a passion for delivering training; fluent in German, good command of English.
- Technical know-how to assess requirements, tests, and software.
- ISTQB certification or further training in computer system validation is desirable.
What we offer
- A secure job, even in times of crisis.
- A family-like atmosphere and values.
- Regular working hours.
- Training and professional development.
- Attractive employee discounts with our partners.
- Tax-free non-cash benefits.
- Company pension scheme.
- Capital-forming benefits.
- 30 days of vacation, including a time account.
Benefits
Health, fitness & fun
Topics you will work on
Job locations
About your employer
MSK Pharmalogistic GmbH is an established family business that has been operating in the pharmaceutical industry for over 25 years, offering comprehensive logistics and contract packaging services.
- Established Company
- Onsite
- Pharmaceutical Sector, Chemical Industry, Biotech
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