Founded in 1968, SKAN is a pioneer in cleanroom equipment and the development of isolators for the pharmaceutical industry. Innovative products, tailor-made solutions and an effective service organisation have made SKAN a market leader and a key partner to industry and research laboratories. At SKAN, healthy growth is important to us. We are always looking for talented individuals to fill a wide range of roles. Apply now!

Overview

For the Quality Assurance department we are looking for a person in aseptic manufacturing (biologics and ATMPs) to help build up the quality system and use their broad expertise to support the team its further development.

Responsibilities

• Responsibility for physical/chemical laboratory tests (pharmaceutical excipients, packaging materials)
• QA responsibility in the area of technical transfer
• Further development of our pharmaceutical quality management system
• Collaboration in ensuring the fulfilment of GxP-relevant requirements in operations and processes in the area of aseptic production
• Creation, maintenance and administration of QMS documents (e.g. SOPs)
• Carrying out document reviews (e.g. general GxP-relevant documents, GMP manufacturing documentation for product releases, review and release of electronic Master Batch Records in the Manufacturing Execution System (MES))
• Support in the investigation of deviations incl. writing of investigation reports in English in compliance with specified timelines
• Risk assessment in interdisciplinary meetings. Definition of appropriate corrective and preventive actions
• Collaboration in the training and qualification of staff
• Planning and carrying out audits and official inspections

Hardskills

• Studies in natural science fields (e.g. pharmacy, chemistry, pharmaceutical technology, biotechnology, biology, etc.)
• Min. 2 years of professional experience in quality assurance in a GMP environment, preferably in the field of aseptic manufacturing
• Familiar with legal requirements and regulations in the pharmaceutical industry
• High understanding of quality assurance aspects and GMP documentation in the pharmaceutical environment
• Good German language skills, very good written and spoken English skills
• Ideally experience in the use of electronic quality management systems and MES

Softskills

• Enjoy working in a team
• Precise, structured and reliable way of working
• High level of commitment, independence and pragmatism
• Ability to set and consider changing priorities
• Good analytical understanding
• Ability to work under pressure and assertiveness
• Openness, ability to work in a team and good communication skills
• Willingness to travel 5-10 % (Europe, USA, Japan)

We offer you

• An open and collegial corporate culture
• Freedom for ideas
• Participation in sports and leisure activities
• Promotion through further training, especially at our SKAN Academy
• Intensive and job-oriented introduction
• Short decision-making paths and flat hierarchies
• Open communication policy
• 5 weeks holidays and the possibility of further holidays

For questions please contact Ivana Batt