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Quality Control Project Support
vor 3 Wochen
Founded in 1921 and headquartered in Mendrisio (Switzerland), SINTETICA's mission is to continuously strive to improve therapies by enhancing its products' formulations and usability for the benefit of clinicians and patients.
We do so in close cooperation with clinical experts, who shape our understanding of their unmet needs and drive our efforts to address them. With this trust and insight, we push the limits of science and technology to make therapies safer for patients and easier to perform. Every year we reliably supply millions of doses of our products across a range of therapeutic classes, including anaesthesia and analgesia, while expanding to address further healthcare needs.
**Position summary**
SINTETICA's industrial site in Mendrisio, Ticino, is undergoing a profound transformation and exponential growth. One of the projects currently underway is the construction of a new analytical laboratory, which will perform microbiological, materials and GMP chemical quality control analyses. This laboratory will be at the forefront of instrumentation and data digitization.
In addition, the company carries out projects for continuous improvement and adaptation to new regulations in force (e.g., the new version of EU-GMP Annex 1).
The position is fixed-term for 1 year, at 80%.
**Essential tasks and responsibilities**
The 'QC Project Support' will have to:
- Manage projects currently underway in the Quality Control department, specifically:
- Monitor the progress of projects, through updating the Gantt Chart and managing periodic update meetings.
- Set up project budgets.
- Manage relationships with suppliers involved in the installation of new instrumentation.
- Participate in technical project meetings with the various departments involved, such as Quality Assurance, Engineering and Maintenance, IT, Automation, Scientific Affairs.
- Provide support in drafting GMP documentation related to projects.
- Take care of monitoring the update of current regulations, such as European and American Pharmacopoeia, EU-GMP Annex 1.
- Provide support in managing and drafting Quality Control GMP documentation (SOPs, validation protocols, deviations, Change Control Forms).
**Required skills and core competences**
The 'QC Project Support' must have:
- A bachelor's degree in a scientific discipline. Ph.D. will be considered an asset.
- At least 3 years of experience in research laboratories or in the pharmaceutical field.
- Ability to manage projects (use of MS Project will be considered an asset).
- Ability to work in a team.
- Open-minded and innovative approach.
- Experience with literature searches and creating and updating documentation.
- Good knowledge of spoken and written English, knowledge of French will be considered an asset.
**We offer**
Fixed-term employment in a young, dynamic working environment and positive culture.
Sintetica promotes Diversity and Gender Equality.
