Commisioning, Qualification and Validation

CQV-quality supports commisioning, qualification and validation activities across:

• Design review (DER) and design qualification (DQ)
• Factory (FAT) and site acceptance test (SAT)
• Installation (IQ), operational (OQ) and performance qualification (PQ)

Of :

• Equipment and process plants including the automation part 
• Climate-controlled facilities
• Utilities
• IT-systems

By the use of a science- and risk-based validation approach (SRV), if requested. 

Furthermore, my work has included preparation, review, and management of:

• Validation master plans
• Requirement specifications 
• Risk assessments

All managed through interdisciplinary collaboration with among other Technicians, Project Managers, Quality Assurance and Vendors.

GxP and Quality Assurance in General

CQV-quality is ready to assist with various different sort of GMP quality and compliance activities.

I combine strong theoretical knowledge with extensive practical experience to deliver pragmatic, robust, and compliant solutions aligned with current regulatory requirements, guidelines, and standards.

Drawing on a strong foundation in quality management, I offer the development of:  

• Overall commissioning, qualification, and validation strategies
• Clear, effective, and compliant instructions

My previous operational responsibilities have also included:

• Change control 
• Corrective and preventive actions (CAPA)
• Deviations

I have comprehensive knowledge of regulatory requirements and industry standards, such as: 

• EU GMP guidelines (EudraLex volume 4)
• FDA regulations (21 CFR)
• ICH guidelines (Q8/Q9/Q10)
• ISPE guidelines (GAMP 5, etc.)
• ISO standards (ISO9001/ISO13484/ISO14644/ISO 17665/ISO17025)

Calibration

CQV-quality provides selected services within calibration.

Calibration has formed an integral part of my previous responsibilities, including uncertainty calculations, determination of calibration intervals, definition of calibration points and acceptance criteria, and monitoring of process alarm systems.

In addition, my responsibility for ISO accreditation of a calibration laboratory has provided me with specialized knowledge of accredited calibration processes and regulatory requirements.

Project Management

CQV-quality can handled your needed project managment roles.

I have developed strong capabilities in managing projects, including responsibility for quality, timelines, and costs in connection with equipment upgrades and as well as the procurement of new production equipment.

Naturally my roles as project manager have involved the use of key project management tools such as:

• Stakeholder analysis and handling
• Risk assessment
• Clarification of framework conditions
• Continuous project follow-up

These activities have required close collaboration with both internal and external stakeholders, including Consultants and Vendors. 

Quality Management and Leadership

CQV-quality provides the experience and expertise to lead your quality-related projects and other ongoing quality activities. 

Through CQV-quality, I offer an extensive management profile encompassing daily operations and long-term strategic business responsibilities. 

As a Team, Department, and Site Manager, my responsibilities have included setting objectives, monitoring progress, managing budgets, coordinating project portfolios, and resource planning. 

My management experience also encompasses employee motivation and coaching, Lean-based process optimisation, and the oversight of initiatives focused on quality, the working environment, and operational performance.

Sales and Customer Care

CQV-quality is ready to help concerning sales and customer care within your business.

Through experience in the consulting business, I have developed strong competencies in customer relationship management, including daily customer engagement, identification of sales opportunities with existing as well as new customers, preparation of quotations, and development of sales material.

With CQV-quality, you gain a CQV partnership built on strong advisory capabilities, business understanding, and a clear focus on customer needs.