Q&c Schollmeier

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