Gardening: Own garden with fruits, vegetables and herbs
Nicole Schamberger
QA Release Manager
Habsheim
Summary
Highly skilled and dedicated QA Release Manager with more than five years of experience in assuring quality, safety and efficacy of APIs that are supplied to the market. Possesses a very professional attitude, analytical mindset with a quick grasp and sound knowledge of SAP, LIMS and electronical quality management systems. An effective communicator with attention to detail and strong teamwork skills that enabled to accomplish corporate goals and exceed customer expectations.
Work permit G for Switzerland until 31.01.2028
Overview
8
8
years of professional experience
3
3
Languages
Work History
QA Release Manager
Bachem AG
Bubendorf
06.2020 - Current
- Release and certification of GMP API batches (generics and NCEs) as delegate of the Responsible Person (FvP) according to Swiss law
- Review and approval of analytical instructions, product specification, master batch records (paper-based and eMBRs) and related change controls
- Review and approval of deviations in analytics and manufacturing, related CAPAs, non-conformance material reports and further GMP related documents
- Assuring and continuously improving the quality management system and cGMP compliance
Manager QA
Celonic AG
Basel
02.2018 - 05.2020
- Demonstrated leadership skills in managing projects from concept to completion as QA representative (e.g. coordination of review of plans and reports from cell line development to batch record review and preparation of DS releases)
- Process Owner of change control process and CAPA Policy, including training, continuously improving and promoting these processes
- Review and approval of deviations, CAPAs, change controls, risk assessments, specifications, SOPs and further quality related documents
- Preparation and execution of audits and self-inspections
Trainee DSP Process Development
Celonic AG
Basel
05.2017 - 01.2018
- Planning and practical execution of small-scale feasibility runs to scale-up verification runs (from harvest to formulation) for customer projects
- Supporting activities for DSP GMP production in the clean rooms
Intern
Romer Labs Diagnostic GmbH
Tulln/Donau
08.2015 - 10.2015
- Extraction and purification of DNA of animal feed for GMO analysis
Education
Master of Science - Biotechnology
University of Natural Ressources And Life Science
Vienna 10.2014 - 2017.04
Bachelor of Science - Biotechnology and Environmental Engineering
University of Applied Sciences Upper Austria
Campus Wels 10.2011 - 2014.06
Skills
GMP guidelines and regulations
Interests
Cooking and healthy nutrition
Hiking in the Alps
Yoga & Pilates
Timeline
QA Release Manager
Bachem AG
06.2020 - Current
Manager QA
Celonic AG
02.2018 - 05.2020
Trainee DSP Process Development
Celonic AG
05.2017 - 01.2018
Intern
Romer Labs Diagnostic GmbH
08.2015 - 10.2015
Master of Science - Biotechnology
University of Natural Ressources And Life Science
10.2014 - 2017.04
Bachelor of Science - Biotechnology and Environmental Engineering
University of Applied Sciences Upper Austria
10.2011 - 2014.06
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