Group Analytical Specialist QC (m/f/d) - Method Validation
Job ID: 60601 Location:
Springe, DE Wien, AT
Job Level: Professionals Job Category: Quality Employment Type: Permanent position Career Level:
Become part of a vital chain and contribute to our common goal of making people’s lives better. Octapharma is a leading biotech pharmaceutical company that combines the strength of a global organisation with the values of a family business. We specialize in the development and manufacture of high-quality pharmaceuticals derived from human blood plasma and human cell lines.
The position will be filled in either Springe (Germany) or Vienna (Austria).
Join us in shaping our vision of providing new health solutions advancing human life.
Your main tasks and responsibilities
1. Prepare validation documents and other GMP-relevant documents with the support of senior analytical specialists and team leaders
2. Develop and validate methods
3. Support troubleshooting in the QC laboratories
4. Manage sample administration and follow-up of validation-related testing in the QC and R&D laboratories
5. Support method transfer and the issue/update of product specifications
6. Administer documents required for submission and assist with inspection tasks
7. Prepare statistical evaluations of data and reports using Excel
Your expertise and ideal skill set
8. University degree (MSc, PhD, or equivalent) in Chemistry or Biosciences
9. Work experience in the pharmaceutical industry, especially in the field of method validation (GMP environment), is a plus
10. Willingness to travel for business (approx. 5% per year, domestically and internationally)
11. Good knowledge of MS Word and MS Excel
12. English communication skills (oral and written)
13. Strong social and presentation skills
14. Strong problem-solving, organizational, and time-management skills. Ability to multitask and a high level of flexibility
Your department - where you make an impact
15. We, the Quality Unit, are responsible for the review and approval of pharmaceutical products. This involves ensuring that all products comply with legal requirements and are suitable for their intended use in terms of safety, quality and effectiveness. Defining, improving and checking compliance with the quality system is just as much a part of the job as carrying out laboratory tests and checking all documents.
16. The Quality Unit is divided into the departments Quality Assurance, Quality in Operations, Quality Control and Assessment & Release.
Thrive with us
17. Company restaurant & meal subsidy
18. Training & further education
19. Health promotion
20. Parking spaces and good public transport connections
21. Company and team events
Enjoy these attractive benefits! You can find all offers here:
The minimum gross salary according to the austrian collective agreement (chemical industry) is EUR 4.270,14 based on 38 hours per week (full-time). As we strive to offer a salary that reflects your individual profile and qualifications, there is a willingness to pay above the minimum salary.
It´s in our blood
We live diversity and stand for equal opportunities as an employer! We therefore look forward to receiving your application - regardless of age, gender, origin, sexual orientation, and religion.
Do you have any questions? Then get in touch with your contact person.
Mr. Jonas Jäckel
Octapharma Produktionsgesellschaft Deutschland mbH
Wolfgang-Marguerre-Allee 1, 31832 Springe
T: +49 504177 918600
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About Octapharma
Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. We employ more than 11,000 people worldwide to support the treatment of patients in 120 countries with products across three therapeutic areas: Immunotherapy, Haematology and Critical Care. With seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany, and Sweden, Octapharma also operates over 195 plasma donation centres across Europe and the US. With four decades of experience, we are committed to advancing patient care worldwide.