Aline Hutter is a QA Manager at Roche Switzerland at F. Hoffmann-La Roche Ltd. She possess expertise in audits, qualification and validation. She is proficient in Französisch and Englisch.
F. Hoffmann-La Roche Ltd
-
Qa ManagerF. Hoffmann-La Roche Ltd Jul 2020 - PresentBasel, Schweiz
-
Head Manufacturing / Deputy Head OperationsSiegfried Pharma Ag Oct 2018 - Jul 2020- 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
-
Team LeaderNovartis Jun 2017 - Aug 2018Schweiz- 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 -
Deputy Of Team Head Clinical Packaging In Drug Supply ManagementNovartis Nov 2016 - May 2017Basel Und Umgebung, SchweizThe 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
-
Process Expert In Drug Supply ManagementNovartis Dec 2015 - May 2017Basel 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
-
Postgraduate In Drug Supply ManagementNovartis Jan 2015 - Nov 2015Basel Und Umgebung, SchweizWorking as a junior Process Expert
-
PharmacistAmavita Apotheke Oct 2014 - Jan 2015Sankt Gallen Und Umgebung, SchweizDeputy of responsible pharmacist with 9 associates
Aline Hutter Skills
Aline Hutter Education Details
-
Pharmacy -
Master Of Science In PharmacyPharmacy -
Bachelor Of Science In Pharmaceutical SciencePharmacy
Frequently Asked Questions about Aline Hutter
What company does Aline Hutter work for?
Aline Hutter works for F. Hoffmann-La Roche Ltd
What is Aline Hutter's role at the current company?
Aline Hutter's current role is QA Manager at Roche Switzerland.
What schools did Aline Hutter attend?
Aline Hutter attended Universität Basel, Master Of Science In Pharmacy, Bachelor Of Science In Pharmaceutical Science.
What skills is Aline Hutter known for?
Aline Hutter has skills like Audits, Qualification And Validation.
Not the Aline Hutter you were looking for?
Free Chrome Extension
Find emails, phones & company data instantly
Aero Online
Your AI prospecting assistant
Select data to include:
0 records × $0.02 per record
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial