Specialist (m/f/x) QA Client Communication

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

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.

If you have any questions, please contact Selin Sencan ( ).

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