13.06.2025 aktualisiert
Premiumkunde
100 % verfügbarSenior Consultant; Interim Management-, Integration- and M&A-Support, EHS
Freilassing, Deutschland
Weltweit
Dipl. Ges. Oec. / Dipl. in Healthcare ManagementSkills
Maschineninstandhaltung21 CfrQualitätsplanungMedizinische GeräteAuditsPrüfungsrisikoBusiness MarketingBatch-DateienBenchmarkingMedical CodingMedizintechnikBusiness DevelopmentISO 9000ReinraumGood Manufacturing PracticesKorrektur- und VorbeugemaßnahmeCertified Professional Medical AuditorMedizinische RichtlinienKommunikationQualitätsauditComplianceKonformitätstestsVertragsmanagementKorrektive InstandhaltungPharmakovigilanzRecords ManagementGesundheit und Sicherheit am ArbeitsplatzFehler ErkennenSterilisationEtikettierungArbeitsablaufdarstellungFmeaGovernance-Risikomanagement und ComplianceMarketingGute Klinische PraxisInterim ManagementInternationale GeschäfteIso 13485ISO14001ISO 14971Iso 50001InstandhaltungVorbeugende WartungProjektmanagementGesundheitsaktenPharmaziePharmakologieProzessfähigkeitProdukt ManagementQualitätsmanagementFernüberwachungLieferantenbewertungSupplier Managed InventoryTechnische DokumentationArchivierungÜberwachung vor OrtVerpackung und KennzeichnungQualitätssicherung für LieferantenInspektion vor Ort8D ReportISO 9100ISO 45001Gmp-gerechte DokumentationMedizinsches MaterialStilllegungFailure Modes, Effects, and Diagnostic Analysis (FMEDA)Produktionsarbeiten im ReinraumRisikomanagementGXPBeschwerdemanagement
QM/ QA/ GMP/ cGMP / GCP / GDP / Regulatory/ Compliance in Medical Devices and Pharmaceutical Companies
Project Management/ M&A-Support / Integration and Decommissioning- Support / FDA Readiness / Auditor ISO for 13485 / MDD / Batch Records and Technical Documentation / EHS-Manager
Pharmaceutical- and Medical Device Industry specific
- GMP, cGMP
- Validation, Verification and Qualification Activities
- Doc. Control / Record Management
- Marketing and Marketing
- Contracts / Agreements
- Project Management
- Product Management
- Communications with Authorities
- Labeling, UDI (EU/FDA) and TrackAndTrace (Pharma)
- Health and Safety Management
Standards, Regulations and Guidelines:
- ISO 9001; ISO 10993-1; ISO 13485; ISO 14155-1 and 14155-2; ISO 17025; ISO 19011; 21 CFR 820; CMDCAS; ICH Q9, Q10; TR 24971; IEC 62971
- 2017/745 (EU MDR) ; 93/42/EEC (MDD); 90/385/EEC (AIMD); 2017/746 (EU IVDR); 98/79/EC (IVDD)
Post Market Surveillance / Vigilance Systems
Risk Management
Site Decommissioning / Interim Management
Auditing and Training
Project Management/ M&A-Support / Integration and Decommissioning- Support / FDA Readiness / Auditor ISO for 13485 / MDD / Batch Records and Technical Documentation / EHS-Manager
Pharmaceutical- and Medical Device Industry specific
- GMP, cGMP
- Validation, Verification and Qualification Activities
- Doc. Control / Record Management
- Marketing and Marketing
- Contracts / Agreements
- Project Management
- Product Management
- Communications with Authorities
- Labeling, UDI (EU/FDA) and TrackAndTrace (Pharma)
- Health and Safety Management
Standards, Regulations and Guidelines:
- ISO 9001; ISO 10993-1; ISO 13485; ISO 14155-1 and 14155-2; ISO 17025; ISO 19011; 21 CFR 820; CMDCAS; ICH Q9, Q10; TR 24971; IEC 62971
- 2017/745 (EU MDR) ; 93/42/EEC (MDD); 90/385/EEC (AIMD); 2017/746 (EU IVDR); 98/79/EC (IVDD)
Post Market Surveillance / Vigilance Systems
Risk Management
Site Decommissioning / Interim Management
Auditing and Training
Sprachen
DeutschMutterspracheEnglischverhandlungssicher
Projekthistorie
Project Responsibilities:
- Support in setting up cleanroom monitoring (particle monitoring in accordance with the ISOs 2083- and 14644- series of standards and biocontamination control in accordance with ISO 17141)
- Support in setting up the cleanroom and the associated infrastructure, IQ, OQ, PQ (supplier management)
- Preparation of Pre-Series Manufacturing Runs
- Support in the creation of associated processes and work instructions for the cleanroom
- Identification and integration of an external testing laboratory and calibration service (in accordance with ISO 17025)
- Support in the preparation of the relevant documents for a planned certification according to ISO 13485
- Training of internal employees in Determination of particle concentration and biocontamination control in the cleanrooms
- Best practice in dealing with cleanrooms (gowning, entry and exit of employees and materials, occupational safety, emergency management, etc.)
- Preparation and follow-up and participation in audits (behaviors, do's and don'ts)
***** Healthcare, a global acting Pharmaceutical and Life Science company
- Marketing- and Benchmarking Audits
- Marketing- and Benchmarking Audits
- Project Responsibilities:
o Support the 2 local Quality Assurance Teams during the ongoing
Integration (Post Acquisition Phase)
o Provide support during Corrective and Preventive Action (CAPAs)
activities and manage the CAPA system.
o Support moving NCs, CAPAs, Complaints and Audits into the new
corporate IT systems.
o Review and update the existing Supplier Quality Agreements against
regular and/or corporate standards
o Partner with Process owners to generate and metrics, which reflect the
health of different Quality System elements.
o Ensure compliance of the existing /and partially in transit) QMS through
authoring and updating Standard Operating Procedures (SOP).
o Organize, prepare, and lead weekly/bi-weekly project progress meetings
with the stakeholders and ensure progress is consistently communicated
to other internal partners.
o Provide support during external audits such as Notified Body and
competent authority audits, including follow-up on actions.
o Train the local employees in audit behaviour and readiness
o Support the 2 local Quality Assurance Teams during the ongoing
Integration (Post Acquisition Phase)
o Provide support during Corrective and Preventive Action (CAPAs)
activities and manage the CAPA system.
o Support moving NCs, CAPAs, Complaints and Audits into the new
corporate IT systems.
o Review and update the existing Supplier Quality Agreements against
regular and/or corporate standards
o Partner with Process owners to generate and metrics, which reflect the
health of different Quality System elements.
o Ensure compliance of the existing /and partially in transit) QMS through
authoring and updating Standard Operating Procedures (SOP).
o Organize, prepare, and lead weekly/bi-weekly project progress meetings
with the stakeholders and ensure progress is consistently communicated
to other internal partners.
o Provide support during external audits such as Notified Body and
competent authority audits, including follow-up on actions.
o Train the local employees in audit behaviour and readiness