Welcome to Q&C @ Schollmeier
About Me: I’m a passionate #Biochemist with extensive experience, dedicated to enhancing Quality and Compliance across the Pharma, Biotech, and MedTech industries. My expertise spans traditional analytical laboratories to cutting-edge digital GXP processes.
EXPERTISE:
#QualityManagementSystems (QMS): Implementing paper-based and digital systems.
#Audit Management: Conducting first-party, second-party, and internal audits; supporting third-party audits.
CERTIFICATIONS:
#TÜVCertifiedAuditor: Experienced in various audit types.
Certified QM Manager (ISO 9001:2015): QMS Implementation, Tracking, and Management.
#CertifiedComplianceOfficer (ISO 19600:2016): Risk Management (ISO 14971:2020).
SERVICES:
#QualityOversight & Compliance:
Settings: GLP, GCP, GMP.
Document & Learning Management Systems: Managing SOP portfolios and compliance.
Start-Up Support: Quality & Regulatory support, including Pharmacovigilance (PV) system setup.
#QualityManagement:
QMS Implementation
QMS Tracking and Managing
Quality Assurance Management
Process and Interface Assessment
Efficiency Improvement via LEAN Management
#ComplianceManagement:
Risk Management (ISO 14971:2020)
Regulatory Support (Post Market Surveillance and Vigilance)
Ensuring aligned compliance for processes and business interfaces
#AuditManagement:
Certified QM Auditor (ISO 19011:2018)
1st and 2nd party Auditing
Internal Audits
CMO Auditing
Self-assessment and status quo
Company Details
- Employees
- 1
- Founded
- -
- Address
- Heidelberg, De
- Industry
- Business Consulting And Services
- NAICS
-
Management, Scientific, and Technical Consulting ServicesManagement Consulting ServicesOther Scientific and Technical Consulting ServicesOther Management Consulting Services
- Website
- http://www.yvetteschollmeier.de
- Keywords
- ISO9001, Quality Management System (QMS), Quality Management, Compliance Management, Quality Auditor, QaaS, Audit Management.
- HQ
- Heidelberg
Q&c @ Schollmeier Questions
Q&C @ Schollmeier's website is http://www.yvetteschollmeier.de
Q&C @ Schollmeier's LinkedIn profile is https://de.linkedin.com/company/q-c-schollmeier
Q&C @ Schollmeier has
1 employees.
View email and phone details for 1
employees at Q&C @ Schollmeier.
Q&C @ Schollmeier's industry is
Business Consulting and Services
Q&C @ Schollmeier's top competitors are
Metawave Project,
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Compliance Consulting Gmbh,
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Ak Jura – Akademie Für Juristische Fachseminare,
Bmcs Advisory & Trainings Müller & Stolzenberger Partg,
Business Support Ag.
Q&C @ Schollmeier's categories are Business Consulting and Services
Q&C @ Schollmeier's founding year is 2024
