Qualification Engineer

Qualification Engineer: Qualification / Data Integrity / GMP / CSV / API Manufacturing / Drug Substance / Changes and Deviations / Qualification Project Plan / English / German

Background:

Pharma Engineering is looking for suitable candidates with experience in both equipment 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).

The perfect candidate has experience in the qualification of production plants as well as validation of computer systems and is familiar with the practical implementation of GMP guidelines. Changes and deviations are drafted flawlessly and presented confidently to regulatory authorities during inspections together with the equipment qualification or CSV.

Work and time management are self-organized and coordinated in agreement with the team and the customers.

Tasks & Responsibilities:

• Creating concepts, QPP (Qualification Project Plan) or VMP (Validation Master Plan)
• Creating qualification/validation plans and reports for all phases according to the Roche quality system
• Carrying out qualifications/validations in all phases according to the Roche quality system
• Evaluating technical changes to equipment regarding their impact on the qualified state and independent processing of requalification activities
• GMP-compliant documentation of the work performed and summary of deviations that occurred
• Developing proposals for solutions to the deviations that occurred
• Familiarization with electronic qualification and validation software

Must Haves:

• Degree in a natural science / engineering course of study or relevant professional experience.
• 3 years of professional experience and sound experience in the qualification process
• Practical professional experience with qualifications/CSV of different types of equipment/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 speaking and writing, good English skills

Reference Nr.: 925156
Role: Qualification Engineer
Industry: Pharma
Location: Basel
Workload: 80 - 100%
Start: Start date
Duration: 12 + Months
Deadline:

If this position has piqued your interest, please send us your complete resume. If this position does not quite match your profile and you would like to receive other positions directly, you can also send us your resume via this ad or to jobs[at]itcag[dot]com.

Contact us for more information about our company, our positions, or our attractive payroll-only program: .

About us:

ITech Consult is an ISO 9001:2015-certified Swiss company with offices in Germany and Ireland. ITech Consult specializes in placing highly qualified candidates for temporary staffing in the fields of IT, life sciences, and engineering. We offer temporary staffing and payroll services. This is free of charge for our candidates, and we do not charge any additional fees for payroll services.

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