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Expert in Qualification and Software Validation

lammhrLandkreis Bergstraße, Hessen, Deutschland
On-site Full-time

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Experience Level

Experience

Qualifications

What You BringA completed degree in Pharmaceutical Engineering or Chemical Engineering – or a technical qualification with relevant further training (e.g., pharmaceutical technician, chemical technician with technician qualification). Experience in pharmaceutical production and solid knowledge of GMP compliance & qualification systems. Experience in computer software validation. Expertise in audit trail reviews, URS development, and risk analyses (e.g., FMEA). Proficiency in MS Office as well as very good German and good English skills. Initiative, a structured working style, and a sense of responsibility. Technical understanding with a pragmatic, solution-oriented approach. A communicative, team-oriented, and resilient personality.

About the job

Are you someone who thinks in processes, has a keen eye for detail, and enjoys ensuring everything runs smoothly? If so, you are in the right place! Our client, a pharmaceutical company with the highest quality standards, is looking for a Specialist in Qualification / Software Validation who will elevate systems and processes with technical expertise and GMP knowledge.

Your Mission

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

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

  • You will be responsible for the planning, execution, and documentation of qualifications and requalifications.

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

  • You will write and update Standard Operating Procedures (SOPs) for the operation and cleaning of systems.

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

  • You will drive the optimization of GMP compliance and assist with regulatory audits.

About lammhr

Join a leading pharmaceutical company committed to maintaining the highest standards of quality. We value our employees, fostering a collaborative and supportive work environment where everyone is treated with respect.

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