Specialist in Qualification and Software Validation (Human)

💡 Do you think in processes, have an eye for detail, and love it when everything runs according to plan? Then you're in the right place! Our client, a pharmaceutical company with the highest quality standards, is looking for a Specialist in Qualification / Software Validation (Human) who will elevate plants and processes to a new level with technical know-how and GMP expertise.

⚙️ Your Mission

• You ensure that existing plants in pharmaceutical production (e.g., filling plants, pure media plants, autoclaves) comply with GMP requirements.

• You create and maintain recurring assessments, annual requalifications, and audit trail reviews.

• You take on the planning, execution, and documentation of qualifications and requalifications.

• You develop URS (User Requirement Specifications) and conduct risk analyses in accordance with GMP guidelines.

• You write and update SOPs for the operation and cleaning of plants.

• You support audits, create deviation reports, change control requests, and CAPAs.

• You drive the optimization of GMP compliance and support during regulatory audits.

🏆 What you bring

• A completed degree in Pharmaceutical Engineering or Chemical Engineering – or a technical apprenticeship with corresponding further training (e.g., Pharmacist, Chemist with Technician training).

• Experience in pharmaceutical production and solid knowledge of GMP compliance & qualification systems.

• Experience in computer software validation.

• Expertise in audit trail reviews, URS creation, and risk analyses (e.g., FMEA).

• Proficient in MS Office, as well as very good German and good English language skills.

• Initiative, a structured way of working, and a sense of responsibility.

• Technical understanding with a pragmatic, solution-oriented approach.

• A communicative, team-oriented, and resilient personality.

What awaits you

✅ Friendly colleagues & small teams – People count here!
✅ Good work-life balance – Home office partially possible.
✅ Attractive remuneration plus company pension scheme & supplementary health insurance.
✅ Flat hierarchies & lots of scope for creativity – Your ideas are in demand!
✅ Top further training opportunities & modern workplaces.
✅ Additional benefits such as free coffee & water, meal allowance, corporate benefits & on-site parking.

🚀 Ready for an exciting challenge? Then apply now – we look forward to hearing from you!

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