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


Q&C @ Schollmeier

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Q&C @ Schollmeier

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Teams

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