Qualification Engineer in the area of Drug Substance

Roche Schweiz bridges the gap between pharmaceuticals and diagnostics. Important research and development functions are located here. For our long-standing client, F. Hoffmann - La Roche AG in Basel, we are looking for a

Qualification Engineer in the area of Drug Substance

Background:

Pharma Engineering is looking for suitable candidates with experience in both plant qualification in the area of Drug Substance (API manufacturing) and in the area of Computer System Validation (CSV).

The working environment includes process plants, media, energies, air conditioning such as reactors, fermenters, centrifuges, purified water, steam, autoclaves, cleanrooms as well as the associated controls and process control systems (CSV).

Tasks & Responsibilities:

• Creation of concepts, QPP (Qualification Project Plan) or VMP (Validation Master Plan)
• Creation of qualification/validation plans/reports for all phases according to the Roche quality system
• Execution of qualifications/validations in all phases according to the Roche quality system
• Assessment of technical changes to plants regarding the influence on the qualified state and independent processing of requalification activities
• GMP-compliant documentation of the work performed and summary of the deviations that occurred
• Development of proposed solutions for the deviations that occurred
• Training in an electronic qualification and validation software

Must Haves:

• Degree in a natural science / engineering course of study or relevant professional experience.
• Min. 3 years of professional experience and sound experience in the qualification process
• Practical professional experience with qualifications/CSV of various types of plants/systems and rooms/media
• Several years of experience in the GMP area with in-depth understanding of quality systems and the lean implementation of GMP requirements
• Good knowledge of the topic "Data Integrity"
• Very good German skills in spoken and written form, good English skills

What is offered to you:

• A chance to participate in one of the most significant pharmaceutical companies in the world
• Modern campus with lots of green spaces and meeting zones
• Varied activity profile
• Further training opportunities through temptraining
• Collaboration in a dynamic and motivated team

You are welcome to send your complete application documents to Frau Marianne Buser.

Basel Basel-Land Aargau Chemie VMP QPP CSV GMP Ingenieur Qualifizierung Ingenieur Qualification Engeneer

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