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Location
In office (Skopje)
Seniority
Senior · 5+ years exp
Employment
Full-Time

Confirmed on the employer's own hiring board on Nov 11, 2026. First seen by Alion on Nov 10, 2026. Gerresheimer scores B on the Alion truth index.

Overview
Company
Impact
Profile match
Gerresheimer is a German manufacturer of pharmaceutical primary packaging and drug delivery systems in glass and plastic, headquartered in Düsseldorf. With about 13,000 employees and 39 production plants in Europe, the Americas and Asia, it makes vials, ampoules, cartridges, prefillable syringes, insulin pens, inhalers and cosmetic glass packaging, and its shares trade on the Frankfurt Stock Exchange. It recruits machine and plant operators for glass production, mechatronics and electronics technicians, automation maintenance and process technicians, shift engineers, PLC programmers, accountants and apprentices at sites in Germany, Poland, North Macedonia and the US.

Gerresheimer is the global partner for pharmaceutics, biotech, healthcare, and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging solutions and drug delivery systems. The company is an innovative solution provider from concept to delivery of the end product. Gerresheimer achieves its ambitious goals through a high level of innovative strength, industrial competence and concentration on quality and customer focus. In developing innovative and sustainable solutions, Gerresheimer relies on a comprehensive international network with numerous innovation and production centers in Europe, America and Asia. Gerresheimer produces close to its customers worldwide with around 11,000 employees and generated annual revenues in 2022 of EUR 1.8bn. With its products and solutions, Gerresheimer plays an essential role in people's health and well-being.

www.gerresheimer.com

  • Independently plan, coordinate, and execute qualification and requalification activities, as well as validation activities within projects, including the evaluation of test results, changes, and deviations.
  • Monitor and ensure the implementation of quality-related activities associated with qualification and validation processes.
  • Prepare and maintain relevant documentation in English, in accordance with applicable standards, guidelines, and regulatory requirements. Preparation and maintenance of relevant documentation in German is considered an advantage.
  • Support and coordinate risk management activities within projects and processes, where necessary.
  • Assess changes and their potential impact on the qualified and validated status of test methods, processes, systems, and equipment.
  • Prepare customer declarations and related documentation, and communication with customer when necessary.
  • Create, maintain, and update test and sample sets.
  • Provide support during internal, external, and supplier audits.
  • Independently develop, revise, and improve relevant operational procedures, work instructions, forms.
  • Drive continuous improvement initiatives within the area of responsibility.
  • Documentation management and good documentation practice
  • Completed technical university degree (minimum three years of academic education).
  • At least five years of relevant professional experience in quality assurance, qualification, and/or validation.
  • Specialized knowledge and practical experience in verification and validation processes.
  • Good command of IT applications, including MS Office, MES, and Quality Management systems.
  • Knowledge of structured problem-solving methodologies (e.g. KT).
  • Strong technical understanding and the ability to work with technical specifications.
  • Familiarity with project management methodologies and tools.
  • Structured, systematic, and detail-oriented approach to work.
  • Good command of written and spoken English.
  • German language skills are considered an advantage

Be part of a team where quality makes a difference!

Join our international environment and contribute to ensuring the highest standards of quality, compliance, and continuous improvement. Your expertise will play an important role in maintaining reliable processes and supporting successful projects.

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