simtrabps
1 day ago
Senior Specialist (m/f/d) GxP Training
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Company information
- Company
- simtrabps
- Location
- Halle, North Rhine-Westphalia Germany
- Posted
- 1 day ago
Job description
Simtra is a first-class contract development & manufacturing organization that has been bringing sterile, injectable medicines to market for over 65 years in collaboration with more than 60 international clients worldwide. Our main focus here is on the production of cancer therapeutics. With the support of over 2,000 employees at our three locations in Bloomington, Indiana, USA; Parsippany, New Jersey, USA, and Halle/Westfalen, Germany, we can offer our clients a broad portfolio of administration systems, including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials, and sterile crystallization. In addition to GMP manufacturing, we also offer other services, including support with formulation and development, freeze-drying optimization, global regulatory support, and secondary packaging.
Simtra is formed from diverse teams in various areas! Become a part of the team and support us in providing life-changing medicines to patients worldwide in the future.
In our plant in Halle/Westfalen, we produce medicines for the therapy of various cancer and other life-threatening diseases.
For our team, we are looking for you as a Senior Specialist (m/f/d) GxP Training.
In this position, you will support the execution and further development of GxP training activities at the site and ensure compliance with regulatory training requirements. This means in detail:
- Maintenance and administration of training documentation, records, and training materials
- Support in the preparation of audits and inspections by providing relevant training records
- Maintenance and updating of training plans and training matrices
- Collaboration with LMS administrators to ensure correct training assignments and training data
- Processing of training-related requests in the LMS, e.g., assignments, records, or deadline extensions
- Support in the continuous improvement of training processes and training materials
- Close collaboration with Quality, functional departments, and other stakeholders to ensure compliance
You bring with you:
- Successfully completed vocational training with corresponding further education or a degree in Life Sciences, Quality, Human Resources, Education, or a comparable field
- 2 to 4 years of professional experience in a GxP-regulated environment
- Good knowledge of GxP training requirements and role-based training concepts
- Experience in maintaining training matrices, curricula, or training programs
- Experience in supporting audits and inspections is an advantage
- Structured and meticulous work approach with a high degree of accuracy
- Strong communication and teamwork skills
- Ideally, experience with Learning Management Systems (LMS) and knowledge of ALCOA+ and data integrity principles
We offer you:
- Fair collective agreement remuneration including social benefits such as a 13th month's salary, vacation pay, company pension scheme, and additional health insurance
- In-house modern canteen with attractive subsidies
- 30 days of vacation plus special leave
- Weekly working hours of 37.5 hours
- Job bike leasing
- Corporate Benefits: Exclusive discounts for employees at numerous well-known brands
- Good public transport connections and free employee parking spaces
- Relocation due to work? We offer financial support within our relocation cost allowance
- Free company sports activities e.g., badminton, soccer, and fitness classes
We offer interesting opportunities in all phases of professional life to dedicated and talented individuals. Gender, age, skin color, origin, sexual orientation, and disabilities play no role – quite the opposite: we promote diversity and believe that diversity is an asset.
We welcome the submission of your professional career documents directly through our online system.
For questions, please feel free to contact Selin Sencan -----
To learn more about Simtra's privacy policy, please read the global privacy policy of the Simtra Recruitment Platform: » Recruiting Privacy Notice (DE)
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