Job
- Level
- Experienced
- Location
- Leverkusen
- Working Model
- Hybrid, Onsite
- Job Field
- Test/QA
- Employment Type
- Full Time
- Contract Type
- Temporary employment
- Salary
- 88.900 to 108.000€ gross/year
Job Summary
In this role, you will ensure Quality Oversight for GMP-relevant computerized systems, review and approve documentation, and advise on CSV, Data Integrity, and IT Compliance during audits and inspections.
Your role in the team
- You ensure quality oversight for GMP-relevant computer-based systems throughout their entire lifecycle and ensure that they always comply with regulatory requirements and are operated in a validated state at all times.
- In this role, you will advise departments on CSV, Data Integrity, and IT Compliance, and actively support audits and inspections at the Leverkusen site.
- You are responsible for quality oversight of GMP-relevant computer-based systems throughout the entire system lifecycle.
- You review and approve CSV documentation (e.g., Validation Plans, Risk Assessments, Test Documentation, Traceability Matrix, Reports).
- You ensure the GMP-compliant implementation, qualification, and operation of computer-based systems.
- You evaluate and approve changes to GMP-relevant systems within the scope of the Change Control process.
- You ensure compliance with Data Integrity requirements according to ALCOA+ and assess risks related to electronic data, audit trails, and electronic signatures.
- You support investigations into data integrity deviations and define as well as track CAPA measures.
- You accompany internal audits and regulatory inspections, ensure documentation remains inspection-ready at all times, and conduct gap analyses as well as compliance reviews.
- You advise and train stakeholders on GMP, CSV, and Data Integrity requirements and drive continuous improvement of quality processes and standards.
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Our expectations of you
Education
- You hold a degree in Natural Sciences, Engineering, Computer Science, Pharmaceutical Technology, or a comparable field.
Qualifications
- You possess comprehensive knowledge in Computerized System Validation (CSV), Data Integrity IT Compliance, and Quality Risk Management.
- You convince through strong consulting and communication skills as well as a confident demeanor towards specialist departments, auditors, and inspectors.
- Fluent in German and English, both written and spoken.
Experience
- You bring several years of professional experience in the pharmaceutical industry, preferably in Quality Assurance, Computerized System Validation, Manufacturing, Engineering, or Quality Control.
- You have several years of experience in a GMP-regulated environment.
- You have experience with Change Control in a regulated environment.
- You have experience in deviation assessment and CAPA management related to computer-based systems.
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What we offer
- The position is limited to 24 months.
- Our service package is flexible, appreciative, and tailored to your lifestyle.
- We ensure your financial stability with an attractive salary ranging from €88,900 to €108,000 per year (full-time), plus a variable component.
- Your compensation is based on your qualifications, skills, and professional experience.
- Whether hybrid work models or part-time work: whenever possible, we give you the flexibility to work how, where, and when it suits you best.
- Your family comes first: We offer caring corporate daycare centers at many locations, support in finding childcare, leave for caring for family members, holiday programs, and much more.
- We promote your development through access to learning and development initiatives, training and workshops offered by Bayer Learning Academy, development dialogues, as well as coaching and mentoring programs.
- We support your health and a self-care lifestyle through various measures, such as free health checks with the company doctor and health seminars.
- We celebrate diversity in an inclusive work environment where you are welcomed, supported, and encouraged to bring your whole personality.
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Benefits
Work-Life-Integration
Health, Fitness & Fun
Higher Take-Home Pay
Topics You Will Work On
Job Locations
About Your Employer
Bayer AG
Bayer AG is a globally active company with core competencies in the life science fields of health and nutrition. We develop our products and services for the benefit of people and the planet, and are committed to addressing the global challenges of a constantly growing and aging world population.
Description
- Company Type
- Established Company
- Working Model
- Full Remote, Hybrid, Onsite
- Industry
- Pharmaceutical Sector, Chemical Industry, Biotech
QA Manager IT
- Salary
- 88.900 to 108.000€ gross/yearEstimated net salary based on the gross salary in the job ad using tax class I.52.680 to 62.183 € net/year · Tax class I
- Location
- Leverkusen
- Working Model
- Hybrid, Onsite
- Diversity
- Open for all genders
