Описание
Simtra is a contract development and manufacturing company that has brought sterile injectable medicines to market for more than 65 years in collaboration with over 60 international customers. It specializes in manufacturing cancer therapies and offers formulation and development support, freeze-drying optimization, global regulatory support, and secondary packaging.
Задачи
- Lead the CSV area at the Halle site
- Implement current CSV/CSA guidelines and regulatory requirements, continuously improve the CSV program, and develop and establish processes and SOPs
- Assess existing, new, and changed IT systems, applications, databases, and tools for validation or CSA relevance
- Plan, coordinate, and conduct CSV/CSA activities in accordance with internal requirements and regulatory expectations
- Contribute to projects involving CSV requirements, including risk-based assessments, documentation, and follow-up
- Conduct CSV-related investigations into GMP deviations, define appropriate CAPAs, and assess their impact
- Prepare and analyze KPIs, trend analyses, and reports on the effectiveness and robustness of the CSV program
- Present CSV/CSA topics during customer audits and regulatory inspections, and answer subject-matter questions
- Collaborate closely with local departments, IT, global CSV and IT teams, and partner sites
Требования
- Bachelor’s, master’s, or diploma degree in a scientific, technical, or IT-related field, such as a STEM discipline
- At least 5 years of experience in data management, IT systems, or CSV/CSA in a GMP environment
- Strong communication skills, logical thinking, and a solution-oriented approach
- Very good written and spoken German and English
- Будет плюсом: Knowledge of relevant regulatory requirements and guidelines, including EU GMP Annex 11, PIC/S PI 041-1, FDA Computer Software Assurance, ICH Q9(R1), ISPE GAMP 5 Second Edition, and ISPE Pharma 4.0
Условия
- Salary is governed by a collective agreement and includes social benefits, a 13th collective-agreement salary, and vacation pay
- Occupational pension plan and supplementary care insurance
- Subsidized modern on-site cafeteria
- 30 Days of annual leave plus special leave
- 37.5-Hour workweek
- Job bike leasing
- Corporate Benefits discounts at well-known brands
- Good transport links and free employee parking
- Financial support for work-related relocation through a relocation allowance
- Free company sports, including badminton, football, and fitness classes
- The company promotes diversity and equal opportunity regardless of gender, age, skin color, origin, sexual orientation, or disability
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QA team lead for computer systems validation (manual) in Halle Arbeitgeber: Simtra
Simtra BioPharma Solutions ist ein hervorragender Arbeitgeber, der seinen Mitarbeitenden nicht nur eine faire tarifgebundene Vergütung und umfassende Sozialleistungen bietet, sondern auch ein modernes Arbeitsumfeld in Halle/Westfalen, das durch eine engagierte und vielfältige Unternehmenskultur geprägt ist. Mit 30 Tagen Urlaub, flexiblen Arbeitszeiten und zahlreichen Möglichkeiten zur beruflichen Weiterentwicklung unterstützt Simtra seine Mitarbeitenden dabei, ihre Karriereziele zu erreichen und gleichzeitig einen bedeutenden Beitrag zur Herstellung lebensverändernder Medikamente zu leisten.
