Services
At Q&C @ Schollmeier, I offer a comprehensive suite of Quality and Compliance Management services tailored to meet the needs of the Pharmaceutical, Biotech and MedDev industries. The offerings are designed for short to midterm (hourly support, part-time up to a few month) projects, ensuring efficient and timely solutions.
Expertise
1. Quality Management:
TÜV Certified QM Manager (ISO 9001:2015): Implementing and managing Quality Management Systems (QMS), both paper-based and digital.
QMS Tracking and Managing: Ensuring effective monitoring and maintenance of QMS.
Quality Assurance Management: Overseeing quality processes to guarantee product and process excellence.
Process and Interface Assessment: Evaluating and enhancing efficiency through LEAN Management principles.
2. Compliance Management:
TÜV Certified Compliance Officer (ISO 19600:2016): Aligning compliance across business processes and interfaces.
Risk Management (ISO 14971:2020): Identifying and mitigating risks.
Regulatory Support: Providing expertise in post-market surveillance and vigilance, ensuring regulatory adherence.
3. Audit Management:
TÜV Certified QM Auditor (ISO 19011:2018): Conducting thorough 1st and 2nd party audits, internal audits, and CMO auditing.
Supplier Assessment and Auditing: Evaluating and ensuring supplier compliance and quality.
Case Studies
Here are some examples to give you an idea about possible projects that I can support you with:
Project 1: Digital QMS Implementation for a Pharmaceutical Company
Objective: Transition from a paper-based to a digital QMS.
Approach: Comprehensive assessment, system selection, and seamless integration.
Outcome: Improved efficiency, reduced errors, and enhanced compliance.
Project 2: Audit Readiness for a Biotech Start-Up
Objective: Prepare for an FDA audit.
Approach: Conducting internal audits, training staff, and addressing compliance gaps.
Outcome: Successful FDA audit with no major findings.
Project 3: NPI (New product introduction) Project Management in the LifeScience Sector
Objective: Oversee the introduction of a new product.
Approach: Coordinating cross-functional teams, managing timelines, and ensuring regulatory compliance.
Outcome: Timely product launch and regulatory approval.
Project 4: Quality & Regulatory Support for a Biotech Start-Up
Objective: Establish a robust Quality and Regulatory framework.
Approach: Setting up SOPs, supporting Pharmacovigilance (PV) system setup, and bridging quality and regulatory aspects.
Outcome: Enhanced operational efficiency and compliance, facilitating growth and partnerships.
Project 5: Internal Audits for ISO 9001 Certification
Objective: Fulfill ISO 9001 certification requirements through comprehensive internal audits.
Approach: Planning and executing internal audits, identifying areas for improvement, and providing corrective actions to meet ISO 9001 standards.
Outcome: Successful ISO 9001 certification, demonstrating commitment to quality management and continuous improvement.
