A free spirit, with diverse interests and a people-oriented personality. Always on the lookout for new challenges, both at work and in many hobbies. Demanding of herself, both physically and mentally.
Skills
AbfüllenSterilisation
Approximately 25 years’ experience in the international GxP regulated field of the pharmaceutical industry.
Excellent know how in business processes and overview of pharmaceutical business along the supply, value stream and life cycle of pharmaceutical products.
Very strong knowledge in GLP, GCP, cGMP requirements and general quality requirements.
Very good experience in preparation for Inspections and Audits, GAP analysis, remediation projects and CAPA processes.
Excellent expertise in technology transfer projects for small as well as large molecules
Very well experience in project management; certified project manager (e.g. Project management in CMO companies).
Strong expertise in downstream processing as head of DS development and technology transfer groups.
Established expertise in pharmaceuticals production; fill and finish especially in aseptic filling, but also tablets, coated tablets or capsules.
Very good knowledge in API production of large and small molecules (upstream, downstream, fill and finish)
Experience in regulatory affairs and dossier preparation (eCDT/CMC part)
Fundamental knowledge in pharmacovigilance
Very good expertise in managing inter-divisional and inter-company’s complex project as well as customer projects.
Very experienced know how in crisis management, pragmatic problem-solving and very good technical understanding.
Excellent leadership and communication and negotiation skills.
Strongly customer/stake holder orientated with profound experience in documentation and presentation.
Excellent knowledge in MS Office (Word, Excel, Power Point, MS-Project
Excellent analytical and conceptional abilities, Open-minded, with the willingness to learn and looking beyond your own nose in combination with a hand-on mentality.
German mother language, English business fluent spoken and written.
Erfahrung
Berufserfahrungmehr als 10 Jahre
Freelancer seit2015
Sprachen
DeutschMutterspracheEnglischverhandlungssicher
Projekthistorie
Project Manager
Curevac
Pharma und Medizintechnik
500-1000 Mitarbeiter
Single point of contact for official control laboratories (OMCLs)
Development and negotiation of the product specific OCABR protocol
Coordination of transfer processes to official control laboratories
Development/definition of release process inhouse
Coordination of batches for EU release by OMCLs
QA GAP analysis and remediation (e.g. implementation change control, implementation incoming goods control, third party management, deviation handling and investigations, batch record review process, complaint process)
Interim Operations Manager Production site
CSL
Pharma und Medizintechnik
>10.000 Mitarbeiter
Process validation
Cleaning validation and cleaning verification
eBBR from Production site
Discussion of exceptions
Implementation of legal requirements, deviation and change control management
Preparation of the production unit for inspection
Process optimization
Consultant QA FDA Inspection readiness
TEVA
Pharma und Medizintechnik
>10.000 Mitarbeiter
FDA Inspection preparation Gap analysis of QMS Processes like Trainings system; Environmental monitoring, Change control. Deviation and CAPA
Identifying risk, and developing remediation strategies
Interim Head of manufacturing aseptic and terminal sterilized products
Livisto Lroup
Pharma und Medizintechnik
500-1000 Mitarbeiter
Managing the sterile fill and finish production
Resources and budget responsibility for the production unit
Lean management project implementation, streamline and optimization of production and the associated business processes, process change management
Project of production increase due to increasing market demands
Implementation of legal requirements, responsible for deviation and change control management
Managing the organizational change of the production unit
Representing the production unit in customer audits and audits by responsible authorities
Responsible for GMP Training of the production people by setting up adequate classroom training
In-house training
Process validation and re-validation.
Cleaning validation and cleaning verification
Validation of Sterilization processes and
Interim Training Manager
Recipharm
Pharma und Medizintechnik
250-500 Mitarbeiter
Review of the existing training system and development of an optimization plan
Definition and implementation of a change control application for the implementation of an onboarding program and centralization of the existing training system in preparation for the introduction of an electrical system
Establishment of the new training system in consultation with global and local QA
Interim Head Compliance Management
CSL
>10.000 Mitarbeiter
Substitute for Head of Compliance during parental leave and taking over the responsibilities for group lead, coordination of activities within the compliance department.
Coordination of interdepartmental topics
Tracking and reporting of the KPIs
Project Manager
Sanofi
Pharma und Medizintechnik
>10.000 Mitarbeiter
Project management reactivation of a biotechnology process (process transfer)
Project prosecution
Creating Project Documents
Leading Project Sessions
Interim Head of global supplier management QA
Pharma und Medizintechnik
50-250 Mitarbeiter
Set up a new cell culture media supplier management group within the global supplier management QA group
Define the requirements for CCM manufacturers and an overall strategy
Align the QA groups of different sites
Interim Head Corporate Quality Post market surveillance
Curevac
Pharma und Medizintechnik
500-1000 Mitarbeiter
Setting up a new post-market surveillance organization
Set up Change control management
Set up Alert system management
Set up Complaint system management
Consultant QA
Novartis
Pharma und Medizintechnik
>10.000 Mitarbeiter
Content development of the ICH M7 project
Process definition and support for writing the relevant SOP
Review and approval of assessments and reports
representative for all quality questions within the project
implementation of the EDQM/EMA requirements regarding N-nitrosamines in medicinal products
Project Manager
Sartorius
Industrie und Maschinenbau
>10.000 Mitarbeiter
Project management of customer projects special machine construction of pharmaceutial machines
Project prosecution concerning timelines and budget
Documentation (CTX) and presentation
Close contact to the stakeholder and the client
FAT/SAT with customer
Consultant MS&T
Novartis
Pharma und Medizintechnik
>10.000 Mitarbeiter
Content development of the ICH M7 project
Process definition and support for writing the relevant SOP
Review and approval of assessments and reports
representative for all quality questions within the project
Consultant due diligence
Glenmark
Pharma und Medizintechnik
>10.000 Mitarbeiter
To check for the client, if the Indian CMO is ready to produce GMP material
Visit/Audit on site in India to determine the GMP standard
Gap analysis and remediation plan
Final report and presentation for the client pointing out the differences between the quality systems
Project Manager
Sanofi
Pharma und Medizintechnik
>10.000 Mitarbeiter
Managing a analytical method transfer from the client to an external company
Develop the project plan in coordination with the parties
Project prosecution concerning timelines and budget
Regular project status presentation to the client
Consultant Process Validation, Re-Validation, CPV
Sanofi
Pharma und Medizintechnik
>10.000 Mitarbeiter
Support for validation of new process steps in an existing process, creation of validation plans and protocols
Support for qualification and validation of a new implemented process. creation of validation plans and protocols
Consultant production qualification process validation and audit preparation
Biontec
Pharma und Medizintechnik
10-50 Mitarbeiter
Support in all areas of the new production (e.g. Training, production requirements, cleaning and cleaning validation etc. GMP Documentation)
Interim site quality head
Mucos pharma
Pharma und Medizintechnik
50-250 Mitarbeiter
Accompany inspection by local authorities and authorities of other countries (e.g. Russia)
Managing the quality assurance and QC department in the company
Resources and budget responsibility for the QA department
Maintenance and optimization of the quality system and implementation of quality risk management
Responsible for all QA activities (including training-program, production, QC, technique etc.)
Preparation of CMOs for audits by the responsible authorities and accompanying the audits
Strong interaction with other departments, RA, art works, development, strategic purchasing, purchasing, logistics, pharmacovigilance and to external partners, CMOs and suppliers
Approving and signing Quality agreements
Accountable for quality product review
Evaluation of the quality systems of potential new partners (due diligence)
Responsible person for training, establishing a GMP training concept and in-house training
Consultant in QA
Biogen (Zug CH)
Pharma und Medizintechnik
1000-5000 Mitarbeiter
Preparation and assessment of different changes and improvement project within supply chain quality department
Launch project for the Japanese market
Establishment of a new supply chain for US market supply
Improvements in projects regarding quality supplier management
Improvements and change projects regarding quality management
Negotiation of quality agreements
Clinical study project
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