Expert Science & Compliance

Simtra is a first-class contract development and manufacturing company which, for over 65 years and in collaboration with more than 60 international clients, has brought sterile, injectable medicines to market worldwide. Our main focus is the manufacture of cancer therapies. With the support of more than 2,000 employees at our three sites in Bloomington, Indiana, USA; Parsippany, New Jersey, USA and Halle/Westfalen, Germany, we can offer our clients a broad portfolio of delivery systems, including pre-filled syringes, liquid/lyophilised vials, diluents for reconstitution, powder-filled vials and sterile crystallisation. In addition to GMP manufacturing, we also offer further services, including support with formulation and development, freeze-drying optimisation, global regulatory support and secondary packaging.

Simtra is formed of versatile teams across a range of areas! Become part of the team and help in future to make life-changing medicines available to patients worldwide.

At our plant in Halle/Westfalen we produce medicines for the treatment of various cancers and other life-threatening diseases. 

For our team we are looking for you as an Expert (m/w/d) Science & Compliance.

In this role you will be responsible for handling quality matters (deviations, complaints, audits) in pharmaceutical production, as well as serving as the interface with quality assurance (internal and external). You will also take on the following tasks:

• Monitoring, coordinating and supporting the handling of deviations ("Deviations") in the production areas
• Contributing to root cause analysis, defining measures (Corrective and Preventive Actions, CAPA) and effectiveness checks
• Initial assessment of the impact of the deviation on the process and product quality
• Describing deviations and measures in English-language reports
• Presenting the production areas in customer and authority audits (walkthroughs, document reviews - "Front Office")
• Handling complaints in cooperation with quality assurance
• Tracking the status of deviations, CAPAs and audit findings and adherence to the associated quality KPIs
• Creating overarching production documents and SOPs
• Handling new or non-standard customer requirements relating to compliance, regulatory or manufacturing processes

You bring:

• A completed degree in science or engineering, preferably in biology, biotechnology or chemistry
• Preferably professional experience in pharmaceutical manufacturing
• Good knowledge of international cGMP requirements desirable
• Experience in technical writing (reports, deviations, findings)
• An independent and structured way of working, as well as flexibility
• Strong communication skills and a confident manner in audits and inspections
• Very good German and English skills, spoken and written

What we offer you:

• Fair collectively agreed pay including social benefits such as a 13th collectively agreed salary, holiday pay, company pension scheme and additional long-term care insurance
• In-house modern canteen with attractive subsidies
• 30 days' holiday plus special leave
• Weekly working time of 37.5 hours
• Job bike leasing
• Corporate benefits: exclusive discounts for employees with many well-known brands
• Good transport links and free employee parking
• Job-related relocation? We provide financial support within our relocation lump-sum allowance
• Free company sports such as badminton, football and fitness classes

We offer committed and talented people interesting opportunities at every stage of their working life. Gender, age, skin colour, origin, sexual orientation and disabilities play no role - on the contrary: we promote diversity and believe that diversity is an enrichment.

We look forward to receiving your application documents detailing your career to date, sent directly via our online system.

If you have any questions, please feel free to contact Dinara Joneleit ([contact details removed]).

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