Aline Hutter Email & Phone Number

Basel, Bs, Ch

Basel, Schweiz

- Personal and functional lead of bulk manufacturing area of solid dosage forms (dispensing, granulation, compression and coating)- Responsibility of product transfers in bulk manufacturing- Ensure a GMP compliant manufacturing process regarding quantity and safety in compliance with authority - and internal requirements- Responsibility for line unit review and release of executed batch records- Ensure an optimal planning of resources and equipment considering cost efficiency- On time production and delivery of produced bulk in accordance with the lead times - Controlling and optimization of manufacturing processes- Subject Matter Expert for internal and external audits and inspections - investigation of deviations and complaints, change control review, CAPA plans- Additional role as Manager Hygiene with the responsibility of planning, execution and evaluation of the microbiological MonitoringDeputy Head Operations - Representation of Head Operations for daily business and projects

Schweiz

- Ensure a smooth manufacturing process, optimal planning of people and machines - Headcount and budget responsibility, people management and development (up to 60 associates)- Management of processes; lead and execute qualification of equipment and validation of process- Lead tactical and daily operational activities; single point of contact for technical support and engineering topics.- Responsibility of correct documentation and consistent compliance - Subject Matter Expert for internal and external audit and inspections- Batch Record review; Investigation of deviations and complaints; change control review; CAPA plans; risk management- Supporting implementation of strategic projects and launches

Basel Und Umgebung, Schweiz

The department is responsible for primary and secondary packaging of clinical and stability studies, in-house label printing and dispensing of API for Novartis Technical Research Development (TRD), Pilot Plants and 3rd parties

Basel Und Umgebung, Schweiz

- Expert for any questions regarding primary and secondary packaging, label printing and dispensing of API- Support in the preparation and management of inspections and audits- Drive process improvement initiatives (e.g. Cleaning Validation)- Responsible for deviation investigations, change control, CAPA plans and risk management- Ensure compliance according to appropriate SOP’s, GMP, GLP, QM, HSE, ISEC and Novartis Guidelines- Provide coaching and technical training as SME or technical expert

Basel Und Umgebung, Schweiz

Working as a junior Process Expert

Sankt Gallen Und Umgebung, Schweiz

Deputy of responsible pharmacist with 9 associates

Swiss Certified Pharmacist (Eid. Dipl. Apotheker), Pharmacy

Master Of Science - Ms, Pharmacy

Activities and Societies: Master Thesis: “Development of a competitive fluorescence polarization assay for affinity (KD) determination.

Bachelor Of Science - Bs, Pharmacy