Job
- Level
- Experienced
- Job Field
- Test/QA
- Employment Type
- Full Time
- Contract Type
- Permanent employment
- Location
- Wedel
- Working Model
- Hybrid, Onsite
Job Summary
In this role, you will optimize the electronic quality management system by harmonizing processes and conducting training, handling deviations and leading CAPA processes, while closely collaborating with the global team.
Job Technologies
Your role in the team
- As a QA Manager (m/f/d) for the electronic Quality Management System (eQMS), you will play a central role in our team and bring your technical expertise to the targeted development of our quality processes.
- In your role as Key User for the eQMS, you act as an interface to the global team, drive the optimization and harmonization of processes, and ensure an efficient and compliant implementation across the entire company.
- Participation in the development and improvement of department-specific workflows in eQMS.
- Participation in the creation and revision of related quality-relevant documents (URS, risk analyses, SOPs, training materials).
- Preparation and execution of training sessions on quality-relevant processes.
- Holistic support for deviations and CAPA processes - from assessment through root cause analysis to the sustainable implementation and follow-up of corrective actions.
- Management of the Change Control process, including review of requests, moderation of relevant committees, and ensuring timely and compliant implementation.
- Participation in globally oriented projects to further develop quality standards and processes.
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Our expectations of you
Education
- Successfully completed studies in the field of natural sciences, pharmacy, IT, or a comparable qualification.
Qualifications
- Knowledge of electronic Quality Management Systems (eQMS) - ideally Veeva.
- Proficient handling of IT systems and data analysis.
- Knowledge in IT system validation according to GAMP (e.g., creation of URS, risk analyses in the form of FMEAs, validation plan, test protocol).
- Ideally, knowledge of national and international regulations for pharmaceuticals (e.g., AMG, AMWHV, EU-GMP guidelines, as well as Code of Federal Regulations Title 21 (US)).
- Solution-oriented and autonomous working style with the ability to structure complex processes and improve them efficiently.
- Fluent in German and English, both written and spoken.
Experience
- Several years of professional experience in a GMP-regulated environment.
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What we offer
- In many departments within the company, our employees can freely arrange their working hours—and work up to 60% remotely.
- We offer 30 vacation days per year and holiday pay.
- At medac, all employees are involved in the company's success: through performance-based bonus payments.
- With company pension scheme and asset-building benefits.
- We offer attractive additional benefits ranging from corporate benefits and accident insurance to external employee consulting.
- The medac Academy offers a versatile range of further and continuing education programs, including language courses and e-learning.
- In our company restaurants in Wedel and Tornesch, there is a varied selection of delicious dishes every day.
- We subsidize the Deutschlandticket and enable BusinessBike leasing for maximum flexibility.
- We offer a wide range of sports activities and health services.
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Benefits
Work-Life-Integration
Topics that you deal with on the job
Job Locations
This is your employer
medac GmbH
Die Medac Gesellschaft für klinische Spezialpräparate mbH is a German pharmaceutical company based in Wedel and Tornesch. 100% privately owned, Medac focuses on therapeutics for the treatment of oncological, urological and autoimmune diseases and their accompanying symptoms.
Description
- Founding year
- 1970
- Company Type
- Established Company
- Working Model
- Hybrid, Onsite
- Industry
- Pharmaceutical Sector, Chemical Industry, Biotech
QA Manager for Electronic Quality Management System
- Location
- Wedel
- Working Model
- Hybrid, Onsite
- Diversity
- Open for all genders
