Spezialist in der Qualifizierung und Softwarevalidierung (Mensch)

Lamm HR GmbH

Contract type

Ongoing

Work mode

Hybrid · Germany

Experience

3 years

Job description

A specialist in qualification and software validation for a pharmaceutical company, ensuring GMP compliance of production equipment and processes.

Ensure existing production equipment (filling lines, purified media systems, autoclaves) meets GMP requirements.
Create and maintain recurring assessments, annual requalifications and audit-trail reviews.
Plan, execute and document qualifications and requalifications.
Develop URS and conduct risk analyses according to GMP guidelines.
Write and update SOPs for operating and cleaning equipment.
Support audits and create deviation reports, change-control requests and CAPAs.
Drive optimization of GMP compliance and support authority audits.

Degree as pharmaceutical engineer or chemical engineer, or technical training with further qualification (e.g. Pharmakant, Chemikant with technician training).
Experience in pharmaceutical production and solid knowledge of GMP compliance and qualification systems.
Experience in computer software validation.
Expertise in audit-trail reviews, URS creation and risk analyses (e.g. FMEA).
Confident use of MS Office and very good German and good English skills.
Initiative, structured working style and sense of responsibility.
Technical understanding with a pragmatic, solution-oriented approach.
Communicative, team-oriented and resilient personality.

Friendly colleagues and small teams.
Good work-life balance with partial home office possible.
Attractive pay plus company pension and supplementary health insurance.
Flat hierarchies and plenty of room to shape things.
Top further training opportunities and modern workplaces.
Additional benefits such as free coffee and water, meal allowance, corporate benefits and on-site parking.

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