Our client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organisation focusses on novel therapies in Oncology and Ophthalmology and is also currently developing a world-leading pipeline in Neuroscience and Dermatology with one of the strongest pipelines of Phase II/III studies in the world. We are currently looking for an enthusiastic GMP Officer to be based in Basel Switzerland.
As an ideal candidate, you will establishe and maintain the GMP management system of the Local Supply Centre, serve as the point of contact between QA and the UNIT for general inquiries, and represent the UNIT in GMP related initiatives.
- Management of cleaning verification activities as well as support and representation of the GMP officer .
- Preparation of the relevant documentation (assessments, protocols and reports) for cleaning verifications related to the production of solid dosage forms in multipurpose facilities and equipment .
- Supporting cleaning verification activities on shop floor.
- Regular updating of the cleaning validation master documents.
- Representation and support of the GMP officer in ensuring overall GMP compliance including the handling of deviations and change controls.
- Preparation and support of internal audits and HA inspections.
- Authorship and review of production and project related GMP documents (Qualification documents, trending reports, SOPs, Logbooks).
- Supporting and giving GMP training in collaboration with other team functions to ensure training compliance .
Qualifications and Experience:
- Pharmacist, Chemist, Pharmaceutical Engineer or other equivalent natural science education.
- Track record of working in GMP environment and having quality- or production-related responsibilities.
- Preferably experience in the field of cleaning validation in drug product or drug substance manufacturing .
- Microbiological Knowledge is a plus.
- Strong interpersonal and communication skills; needs to be a good team player.
- Formal training in continuous improvement methodology such as LEAN/6-Sigma; Green or Black Belt certification is desirable.
- Good project management skills, being focused on results.
- Fluency in English and German is mandatory.
- Relevant working/residency permit or Swiss/EU-Citizenship required.