INTRANET

Quality and Compliance

Practical and effective GMP support

Aptio Group provides Quality & Compliance services for our customers with a practical, effective, and GMP-first approach.

Whether you’re scaling CAPEX capacity or sharpening OPEX reliability, we mobilize the right experts quickly and work shoulder-to-shoulder with your team, delivering GMP compliant outcomes that are robust, lean, and ready for inspection.

We design and upgrade risk-based Quality Management Systems (QMS), provide Commissioning, Qualification and Validation (CQV) services in projects, streamline Quality Assurance (QA) operations, and secure audit and inspection readiness from end-to-end.

Supported areas

CAPEX

  • Commissioning, Qualification and Validation (CQV) Planning, Execution, Review and Reporting
  • Project Quality Management
  • Quality Risk Management
  • Contractor/Supplier Handling and Audits

Typical consultant expertise

  • CQV Lead
  • CQV Engineer
  • Project Quality Manager
  • Quality Risk Manager
  • Contruction Supervisor
  • Contractor/Supplier Auditor

OPEX

  • SOP Preparation and Handling
  • Batch Release Documentation Review
  • Change Control
  • Deviations and CAPAs
  • CMO and Supplier Handling and Audits
  • QMS Preparation and Implementation
  • Gap Analysis and Inspection Readiness
  • GMP Training

Typical consultant expertise

  • Quality Engineer
  • Validation Responsible
  • Auditor
  • Compliance Consultant
  • GMP Trainer

Jan Linke

Vice President - Quality & Compliance

Jan has more than 25 years of experience providing engineering and consultancy services to the pharmaceutical industry.

With an educational background in the engineering, economy, and management disciplines, followed by extensive experience with GMP and validation services, he has a unique ability to help customers secure the right level of GMP compliance and validation in pharmaceutical projects and manufacturing.

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We have a lot of opportunities to try new jobs and challenge your skills. I feel it’s a really cool place to work and I have the best colleagues and management, and we support each other as a team.

There’s a lot of room to grow and develop your skills and it’s a great opportunity to work on different projects with different clients and try new skills. I know my work contribute to something good and it’s a gift to have experienced colleagues.
People stay long in Aptio Group, the team is amazing as the management, who always support education. It feels very safe to have a team you can rely on and have you back though it’s a business, where you meet a lot of new people and clients.

Sometime people know more than you and I wanted to be part of that kind of network.

Personally I have been growing quite a bit due to the task I have been given, so it’s a great way to develop professional.
We have a very good team and collaboration, where we really get the ball moving and are focused on the end goal. We support each other and the hierarchy is flat so I really appreciate the support from the management team.

Join Aptio Group for the interesting projects, to have fun and be a part of a very good community with a family feeling.

Their strong industry reputation and commitment to technical projects across diverse fields made them the right choice. Additionally, Aptio’s flat organizational structure and extensive network were crucial factors in my decision.  

Working at this well-established consulting firm provides me with valuable growth opportunities both personally and professionally, thanks to their expertise and collaborative environment.  

My expertise in Sourcing, Procurement, and Supply Chain, honed over +20 years from different industries, allows me to contribute effectively to the comprehensive package Aptio offers its clients

Exciting Challenges  

The projects I work on are always stimulating. Management keeps me on my toes with complex tasks that push me to grow and excel. It’s a constant adventure of learning and improvement. 

Fantastic Colleagues  

My colleagues are more than just coworkers; they’re friends. Despite being spread across different locations in Denmark and abroad, we’ve formed a tight-knit group. We enjoy wine tastings, dinners, and company trips that blend work and fun. This camaraderie is all thanks to the way management fosters our connections. 

Support When Needed  

I always feel heard and supported. Management is there for me whenever  

I need guidance or assistance, making me feel valued and understood. 

Freedom to Be Myself 

Aptio gives me the freedom to be myself. There’s room for individuality,  

and I appreciate the trust and autonomy I have in my role. 

Why I chose Pharma Engineering and stay with Aptio Group 
My journey into pharma engineering was fueled by a passion for innovation and contributing to the development of life-saving medication. The opportunity to work at the forefront of scientific discovery and technological advancement in the pharma sector was a real motivation. 

A Memorable Start
My Aptio Group story began over coffee in a Danish café where I met Michael Hahn for the first time. His warmth and openness made a lasting impression—and confirmed that Aptio was the place for me. 

Work That Matters
As a mechanical engineer with a focus on HVAC and utility systems, my daily responsibilities include overseeing installation and testing activities in construction. I provide crucial support in developing project documentation, ensuring comprehensive alignment with engineering standards and project goals. 

Always Learning, Always Growing 
The projects are diverse and technically demanding, which keeps me learning and improving. Being part of complex projects allows me to expand my skillset in ways I never imagined. 

Great People, Great Culture 
One of the things I appreciate most is the sense of community. Aptio fosters strong connections through team events, social gatherings, and company trips. Even across borders, we feel like one team.