QA Specialist (QP Delegate)

Fertin Pharma A/S; Vejle; On-site; DKK 650,000 - 850,000; Full time

Job summary

Fertin Pharma A/S in Denmark is seeking a QA Specialist to work close to pharmaceutical operations, ensuring product quality and strengthening manufacturing processes. You will combine day-to-day quality activities with investigations, problem solving, and continuous improvement.

You will collaborate across Quality and Operations, participate in deviation investigations, release of products, reviews of manufacturing docs, and support inspections.

Qualifications

• Educational background is flexible if the candidate understands processes and turns quality issues into practical solutions.
• Experience in pharmaceutical or highly regulated industries is preferred.
• Possession of qualifications for QP Delegate under Danish requirements is advantageous.
• Familiarity with GMP and pharmaceutical QMS is beneficial.

Responsibilities

• Support and approve deviation investigations, including root-cause analysis and CAPAs.
• Provide quality support to manufacturing and participate in release of products.
• Review and approve manufacturing documentation and participate in change controls.
• Contribute to risk assessments and ongoing quality improvement activities.
• Support inspection and audit readiness and cross-functional quality projects.

Skills

Deviation investigations

Root-cause analysis

CAPA

Quality management

GMP

Job description

Do you have a passion for pharmaceutical quality, but also believe that Quality should be about more than compliance?

At Fertin Pharma, we develop and manufacture pharmaceutical and nutraceutical products in partnership with leading global and regional brands, combining pharmaceutical expertise with innovative oral delivery technologies.

We are looking for a QA Specialist who wants to work close to our pharmaceutical operations and help us ensure the quality of our products and continuously strengthen the way we manufacture. You will become part of an environment where GMP, manufacturing, and continuous improvement come together.

About the role:

As QA Specialist, you will collaborate closely with colleagues across Quality and Operations. Your role will combine day-to-day quality activities with investigation, problem solving, and continuous improvement. You will have the opportunity to influence how we work with quality and help move from simply reacting to quality issues towards preventing them through stronger processes and effective collaboration.

• Supporting and approving deviation investigations, including root-cause analysis and CAPAs
• Participating in the release process of our pharmaceutical products
• Providing GMP and quality support to pharmaceutical manufacturing
• Reviewing and approving manufacturing documentation
• Participating in change controls, risk assessments, and quality improvement activities
• Contributing to the simplification of our Quality Management System
• Supporting inspection and audit readiness
• Participating in cross-functional projects where quality expertise is needed

Who are you?

Your exact educational background is less important than your ability to understand processes, challenge constructively and turn complex quality issues into practical solutions. We imagine that you:

• Have a relevant scientific, engineering, or pharmaceutical background
• Preferably have experience from pharmaceutical or other highly regulated industry
• It would be considered a strong advantage if your educational background and professional experience meet the requirements for acting as a delegated Qualified Person (QP Delegate) according to Danish requirements
• Understand GMP and preferably have practical experience working within a pharmaceutical Quality Management System
• Can balance compliance, risk and operational reality
• Have experience with, or an interest in, deviations, CAPA, root-cause analysis and risk management
• Is curious and comfortable asking why
• Communicate clearly and collaborate naturally across functions

If you are motivated by making quality work in practice, not simply administering it, we would like to hear from you.

Special Conditions:

As part of our recruitment process, we conduct background checks on all candidates who accept an offer of employment with Fertin. A satisfactory background check is a condition of employment. The background check is a standard and important part of our hiring process and is carried out in accordance with applicable laws and regulations, as well as Fertin’s internal compliance and integrity requirements.