10.11.2025 aktualisiert
UR
Premiumkunde
Project Manager and Consultant in Pharma
Gstadt, Deutschland
Weltweit
PhD Biochemistry, Master Chemical EngeneeringÜber mich
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
APIsAuditsAbfüllenGeschäftsprozesseGood Manufacturing PracticesSoftwaredokumentationPharmakovigilanzSterilisationProjektmanagementMicrosoft ProjectPharmazieRegulatory Affairs
- 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.
Sprachen
DeutschMutterspracheEnglischverhandlungssicher
Projekthistorie
- 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)
- 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
- FDA Inspection preparation Gap analysis of QMS Processes like Trainings system; Environmental monitoring, Change control. Deviation and CAPA
- Identifying risk, and developing remediation strategies