Quality Assurance Services
Driving Pharmaceutical Excellence & Regulatory Compliance
Looking for trusted Quality Assurance Service to align your pharmaceutical operations with the highest regulatory standards?
I deliver comprehensive QA support tailored to strengthen your Quality Management System (QMS), ensuring product integrity, compliance and continuous quality improvement. Achieving Regulatory Excellence with End-to-End QA Solutions.
- Head of Quality Control according to §12 Abs,1 AMWHV
Comprehensive QA Services for Pharmaceutical Manufacturers
01
Quality System Development & Optimization
Assessment & Process Optimization: Comprehensive evaluation of your existing Quality System to identify gaps and implement strategic enhancements — streamlining quality processes to boost operational efficiency, ensure regulatory compliance and support continuous improvement.
02
Quality Management System (QMS)
QMS Integration and Cross-Site Quality Alignment: Streamlining and unifying corporate Quality Management Systems across multiple locations to ensure consistent standards, enhance collaboration between departments and production facilities and drive operational excellence.
Harmonization of Quality Practices: Development and implementation of standardized processes and procedures to ensure consistent compliance with both EU GMP and FDA regulations, thereby enhancing quality assurance and optimizing global pharmaceutical operations.
03
Policy & Documentation Management
Policy & SOP Development: Drafting and optimization of policies and procedures in line with GMP and regulatory expectations. Creation, review and maintenance of Standard Operating Procedures (SOPs).
Document Control Systems: Implementation of effective document management systems for real-time access and traceability.
04
CAPA & Deviation Management
Deviation Handling & Risk Mitigation: Robust identification and investigation of non-conformities in manufacturing processes, aligned with EU GMP and FDA regulatory expectations. Swift implementation of remediation and preventive actions ensure product integrity, compliance and continuous risk control.
05
Regulatory Project Management
Regulatory Compliance Projects: Expert oversight for projects governed by industry regulations, including Gene Technology Act (§ 15 GenTSV). Proven expertise in managing complex, high-stakes initiatives within tightly regulated environments.
Cross-Functional Coordination: Liaising between departments to ensure project goals align with compliance and business objectives.
Why Choose My
QA Services
Industry Expertise: Extensive experience in pharmaceutical QA, regulatory compliance and quality system development.
Tailored Solutions: Customized QA strategies that address your specific manufacturing and regulatory needs.
Operational Excellence: Supporting your business in achieving consistent product quality and continuous improvement.
Head of Quality Control according to §12 Abs,1 AMWHV
The Importance of Quality Assurance in Pharmaceuticals
In the pharmaceutical industry, Quality Assurance is critical to safeguarding patient health, maintaining market authorizations and protecting your brand reputation. A well-implemented Quality Management System (QMS) ensures compliance with EU GMP, FDA and other global standards, while reducing the risk of product recalls and regulatory penalties.
How My QA Services Can Support Your Business
Strengthen Quality Systems: Build or optimize your QMS to meet evolving regulatory expectations.
Enhance Documentation Control: Ensure up-to-date policies, SOPs and batch records for audit readiness.
Mitigate Risks: Implement robust CAPA systems to proactively address quality issues.
Get in Touch Today
Partner with a QA professional dedicated to supporting your pharmaceutical quality journey. Contact me today to discuss your QA service requirements and learn how I can assist in enhancing your quality systems and ensuring compliance.
Advance your pharmaceutical quality and compliance today with expert QA Services!