Qualification Manager Process Equipment 80-100%

Vor 2 Tagen

Allschwil, Schweiz SKAN AG Vollzeit

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.
- Overview
- We are looking for an experienced person with expertise in equipment qualification in the GMP pharmaceutical environment to further expand our qualification team. In this role, you will be responsible for the implementation and realization of the qualification strategy for our process equipment. You will also be responsible for supporting and coordinating FAT, IQ and OQ as well as preparing the necessary qualification documentation. You can expect a dynamic and committed team. In this role, you will make a decisive contribution to the realization of our projects.
- Responsibilities- Management and implementation of qualification and system conformity tests in projects and service- Developing and coordinating the qualification strategy with internal specialist departments and customers- Creation, review and approval of test documentation, test plans and reports in accordance with applicable standards and guidelines (e.g. GMP, MRL)- Independent processing of deviation reports and analysis of process and system data for quality control purposes- Requirements management, evaluation of the project-specific URS and traceability matrix as well as risk assessments (FMEA, machine safety)- Carrying out customer project audits and specialist training courses- Support and training of project teams and field engineering on qualification issues- International travel approx. 10% incl. travel organization
- Hardskills
- Completed studies (FH/Bachelor) in natural sciences or engineering or technician HF with relevant professional experience
- Experience in quality management, ideally in a GMP environment
- Experience in software qualification (GAMP5) is an advantage
- Confident handling of technical schematics (electrical, pneumatic, P&I schematics)
- Very good written and spoken German and English, other languages an advantage
- Softskills
- Structured and analytical way of working
- High quality awareness and accuracy
- Strong communication skills and team spirit
- Initiative and solution orientation
- 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.

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