Jr Process Engineer

vor 1 Monat

Basel, Schweiz ITech Consult Vollzeit

Junior Process Manager (m/f/d) – GMP / Authority Inspections / Packaging Systems / Pharma / German

Project:
For our client, a large pharmaceutical company based in Kaiseraugst, we are looking for a Junior Process Manager (m/f/d).

Background:

At Roche, 100,000 people in over 100 countries are working on the future of healthcare. Together, we have become one of the leading research-based pharmaceutical companies. Our success is based on innovation, curiosity, and diversity. With its 1,400 employees, the Kaiseraugst production center ensures uninterrupted patient supply with high-quality medicines. In the "Vials Volume" value stream in the Inspection processes team, we are responsible for the visual inspection of various products. We work together with our interfaces from various value streams (logistics, QC, packaging, and filling lines). Various technologies are available to ensure our products are produced with the highest quality and on time.

As a process manager, you will support the group's daily routine operations through technical expertise and troubleshooting. You will advance projects in the individual core elements to improve the process, carry out active change management, and deal with inquiries relating to the department.

Main tasks and areas of responsibility:

  • Representation of the team in local and global investment projects (e.g. acquisition and commissioning of new systems) and expert meetings.
  • Independent planning, implementation, and coordination of comprehensive projects in all areas of activity, such as product transfers and product portfolios.
  • Driving force in the creation and approval of cGMP documents and preparation and implementation of training courses for compliance with cGMP-compliant activities.
  • Management of changes (planned events) and collaboration in the processing of deviations (unplanned events), corrective/preventive measures (CAPAs), internal complaints, and risk analyses.
  • Coaching and support in the implementation of the Lean Production System in the value stream, as well as collaboration in relevant analyses and calculations aimed at improving quality, efficiency, and cost reduction of our processes.
  • Expert in official inspections and audits.
  • Willingness to work in a self-organized team with a high degree of personal responsibility in an open and collaborative environment.
  • Close cooperation with all important areas (neighboring value streams, support units, and other interface partners) to achieve ambitious goals regarding lead time, quality, commitment, and costs in relation to the PT mileposts.
  • Compliance with all safety and environmental regulations, as well as conscious promotion of operational safety.

Must Haves:

  • Completed degree with a scientific/technical background (e.g. microbiology, biotechnology, pharmacy, or comparable).
  • 1-3 years of experience in the pharmaceutical sector, preferably in a parenteral production environment.
  • Several years of professional experience in the GMP environment, as well as good knowledge of GMP and other relevant regulatory topics.
  • Ability to work in a team, flexible, resilient, and able to deal with conflict.
  • Careful, structured, and independent way of working.
  • High ability to work in a team and solution-oriented as well as collaborative working methods.
  • Convincing commitment, knowledge of process improvements, and agile management are an advantage.
  • Ability and openness to recognize and live the opportunities and advantages of change; interest in coaching and change management is an advantage.
  • Fluent written and spoken German is a prerequisite; in addition, very good written and spoken English, convincing communication and presentation skills.
  • Routine handling of IT systems.

Nice to have:

  • Experience in authority inspections and audits.

Reference No.: 923693TP

Role: Junior Process Manager (m/f/d)

Industry: Pharma

Place of work: Kaiseraugst

Workload: 100%

Start: 01.12.2024

Duration: 12++

Application deadline: 09.10.2024

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