Quality Engineering

Quality Engineering Mastery with Amtera

At Amtera, we deliver expert-driven quality engineering services through the strategic deployment of qualified specialists. Our consultants help you implement and maintain best-in-class quality documentation and GMP (Good Manufacturing Practice) compliance across all phases of your project lifecycle.

Leveraging hands-on expertise with leading quality management tools such as TrackWise, Veeva QualityDocs, SAP QM, Oracle QMS, and MasterControl, our professionals ensure that your quality processes are robust, efficient, and audit-ready. We also support QA teams with test management platforms like HP ALM and IBM Rational Quality Manager to streamline assurance workflows and improve traceability.

Key Offerings

Quality Documentation & Validation Support

We provide experienced professionals to develop and manage high-quality documentation tailored to your operations – including SOPs, validation protocols, deviation reports, and audit records – all aligned with current regulatory standards.

GMP Compliance Advisory & Execution

Amtera helps you build and maintain GMP-compliant systems by deploying consultants who understand both the practical and regulatory dimensions of pharmaceutical and manufacturing operations.

Advanced QMS Integration

Our consultants bring experience with SAP QM, Oracle Quality Management, MasterControl, and other platforms to help streamline your documentation, change control, and audit readiness processes.

Quality Assurance & Control Execution

From supplier audits and inspections to CAPA tracking and risk analysis, our QA/AC experts are embedded in your teams to monitor quality proactively and ensure compliance throughout the entire project lifecycle.

Continuous Quality Improvement

Through a combination of industry best practices and workforce insight, we help you implement continuous improvement initiatives to optimise processes, reduce risk, and elevate overall quality performance.

Our Approach

Amtera takes a collaborative and proactive approach. We carefully analyze your specific requirements and provide qualified experts – flexible, skilled, and ready to contribute. With our European network and resource-optimized deployment models, we offer scalable and compliant support for your quality projects.

Partner with Amtera to elevate your quality operations through flexible, managed workforce solutions that deliver measurable results in compliance and performance.