Quality Assurance Manager

vor 2 Wochen

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.

**Responsibilities**:

- 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
- Representation of the F.V.P.

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 Joel Streit

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