SIM
Simtra Deutschland GmbH
Specialist (m/f/x) QA Client Communication
Vor 7 Tagen veröffentlicht
Vollzeit
Halle
Unbefristet
Vor Ort
Ihre Aufgaben
At our plants in Halle/Westphalia we produce drugs for the treatment of various cancers and other life-threatening diseases.
In the role of Specialist (m/f/x) QA Client Communication, you will be the QA representative for clinical and commercial transfer projects. You serve as the main QA-contact for clinical and commercial clients and are responsible for managing the QA-relationship with clients, including oversight of QMS-activities between SMEs and clients. You will be empowered to:
- Translate the client’s needs into QA requirements and provide feedback
- Review of product-specific SOPs / documentation
- Review of validation documents
- Monitoring of Stage-Gate Reviews
- Assure compliance with Simtra and cGMP standards
- Accompanying special manufacturing steps
- Supporting client visits in manufacturing area
- Explanation of Simtra quality standards and quality processes -- details are explained by SMEs
- Advocate for Simtra processes to improve the quality of new manufacturing
- Review of specific NCR
- Support process improvements in QA and Pharma Production
- Support client audits and MOH inspections with regard to client products
- Change Control review and communication to client
What you'll bring:
- Completed studies in Pharmacy, Chemistry, Biology, Technology or a related field
- 3+ years of experience in the Pharmaceutical or Biotech industry
- Experience in Quality Assurance and Aseptic Manufacturing required
- Strong knowledge of cGMP guidelines and microbiology
- Strong ability to deliver training and feedback
- Decisive and solution-oriented mindset, capable of making clear decisions under pressure
- Excellent communication skills in connection with excellent written and spoken German and English skills
What we offer
- Fair, collectively agreed terms of pay, including social benefits such as a 13th month's salary, vacation pay, company pension plan, and additional nursing care insurance
- Modern in-house cafeteria with attractive subsidies
- 30 days of vacation plus special leave
- 37.5-hour working week
- Job bike leasing
- Corporate benefits: Exclusive employee discounts on numerous well-known brands
- Good transport connections and free employee parking with e-charging stations at favorable conditions
- Job-related relocation? We provide financial support as part of our relocation allowance
- Free company sports, e.g., badminton, soccer, and fitness classes
We offer interesting opportunities to committed and talented people. Gender, age, skin color, origin, sexual orientation and disabilities do not play a role - on the contrary: we promote diversity and believe that diversity is an enrichment.
We look forward to receiving the documents relating to your professional career directly via our online system.
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Simtra Deutschland GmbH
Halle
Produktion