We are looking for an independent personality with a passion for Quality Engineering & Management.
Reporting to the Director QM/RA, you are responsible for the maintenance and further development of the IMS / QA with regard to GMP. The ideal candidate will be dedicated to a project and worked as a backup for further projects within the team and bring a "quality mindset" to support quality improvements and compliance.
Your main tasks
- Responsible to maintain our Validation Master Plan including Equipment, Utilities, and Premises Qualification, Computer System Validation, Process Validation.
- To establish risk assessment and to coordinate Change Control activities mainly for technical and quality aspects for Equipment, Utilities and Premises.
- Oversees validation of production processes, performs statistical analysis, develops validation models and writes process validation protocols and final packages.
- Serves as liaison/team member with technical and production departments.
- Review and develop standard operating procedures in compliance with Good Manufacturing Practice (GMP).
- Leads project teams to support GMP compliance for the projects.
What we offer you
- Dynamic, exciting, and challenging work environment with plenty of room to contribute, shape and influence the future development of the Group.
- International work environment with a global customer base.
- Collaboration in a dynamic, open-minded team
- Possibility to work in home office
- In-house restaurant for the employees serving freshly prepared lunch
In this role within an international, world-renowned company, you will enjoy a high degree of flexibility and be able to make a decisive contribution to the realisation of the corporate vision. With its unique safety concept regarding the temperature monitoring of pharmaceutical products, Berlinger plays a significant role to always ensure impeccable quality. In addition to the modern and familiar working environment, a job at Berlinger impresses with this profound sense of purpose in the business field. Add a substantial part to ensure the high quality and development of the company in the future.
Extensive familiarisation with the new tasks and projects will prepare you optimally for your new field of activity. Take the opportunity to become part of our innovative Berlinger team and make your contribution to our road to success.
It was a great honour for us to receive the Switzerland Global Enterprise Export Award 2020. Berlinger convinced the jurors with our internationalization strategy, based on careful market analyses, the cultivation of worldwide partnerships and a clever growth strategy.
- Technical degree or equivalent in life sciences, pharma
- Quality professional with minimum 3 years of hands-on experience in a QA cGMP regulated environment within Biopharmaceuticals or equivalent
- Good knowledge of GMP (US and Europe)
- Working knowledge of Software Validation and of statistics as related to process control
- Working understanding of Risk Analysis (FMEA) and Control
- Experience with Quality Systems to include, Batch Record design/review and supporting investigations
- Good organization skills and attention to detail, with strong verbal and written communication skills
- Proven ability to identify quality issues/discrepancies and effectively and proactively resolve the issues/discrepancies in a flexible and constructive manner
- Fluent English is required
In addition, all instructions and regulations of the Berlinger Group are binding, in particular house rules and QA instructions.
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