Quality Assurance Specialist

Orifarm; Odense; Hybrid; DKK 550,000 - 650,000; Full time

Benefits offered by this job

Hybrid working model

Flexible working hours

Professional growth opportunities

Job summary

Orifarm invites applications for a QA Specialist to support product launches and technology transfers from a QA perspective. You will provide quality oversight and collaborate across functions to ensure timely supply while balancing quality and business needs.

Based in Odense (DK) or Warsaw (PL), you will partner with CMOs and internal stakeholders, review manufacturing documentation, and help ensure compliance with EU GMP requirements.

Qualifications

• Bachelor's or master's degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Engineering or related field.
• Experience in QA/QC, manufacturing, process support or other GMP-regulated environment.
• Solid knowledge of EU GMP requirements.

Responsibilities

• Providing QA support and oversight for product launches and technology transfers.
• Collaborating with CMOs and internal stakeholders to ensure timely and compliant implementation.
• Ensuring documentation and activities comply with approved procedures, specifications, GMP requirements, and regulatory expectations.
• Reviewing and approving manufacturing documentation, including Master Batch Records and Batch Journals.
• Identifying, resolving, and escalating quality and compliance issues when required.
• Participating in change controls, deviations, and risk assessments.
• Driving continuous improvement of QA processes and ways of working.

Skills

GMP knowledge

QA/QC experience

English proficiency

Analytical skills

Education

Bachelor's or Master's degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Engineering

Job description

This position is open for candidates located in Warsaw (PL) area or Odense (DK) area.

Are you passionate about quality, GMP compliance, and supporting successful product launches and technology transfers?

At Orifarm, we are looking for a dedicated Quality Assurance Specialist to join our Innovation & Launch team. You will provide QA support across product launches and technology transfers, ensuring compliance with GMP requirements, internal procedures, and regulatory expectations.

You will work closely with internal stakeholders and Contract Manufacturing Organizations (CMOs) to secure compliant and efficient implementation of new products and processes.

About the job

As QA Specialist, you will support product launches and technology transfers from a QA perspective. You will provide quality oversight, collaborate across functions and help ensure compliant and timely product supply while balancing quality requirements with business priorities.

Key responsibilities:

• Providing QA support and oversight for product launches and technology transfers.
• Collaborating with CMOs and internal stakeholders to ensure timely and compliant implementation.
• Ensuring documentation and activities comply with approved procedures, specifications, GMP requirements, and regulatory expectations.
• Reviewing and approving manufacturing documentation, including Master Batch Records and Batch Journals, as part of the broader QA responsibility portfolio.
• Identifying, resolving, and escalating quality and compliance issues when required.
• Participating in change controls, deviations, and risk assessments.
• Driving continuous improvement of QA processes and ways of working.

Who are you?

You thrive in a fast-paced environment where quality, compliance, and business needs must be balanced. You are structured, detail-oriented, and comfortable taking ownership of complex tasks.

We expect that you:

• Hold a bachelor's or master's degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Engineering, or a related scientific discipline.
• Have experience from QA/QC, manufacturing, process support, or another GMP-regulated environment.
• Experience with manufacturing documentation is an advantage.
• Have solid knowledge of EU GMP requirements.
• Can work independently and manage multiple priorities.
• Possess strong analytical and problem-solving skills.
• Communicate fluently in English, both written and spoken.
• Enjoy collaborating across functions and cultures.

Who are we?

You will become part of a skilled and collaborative QA organization where professionalism, knowledge sharing, and continuous improvement are central to how we work.

In Innovation & Launch, we support product launches and technology transfers across Orifarm's international supply network. We work closely with manufacturing sites, CMOs, project teams, and commercial stakeholders to ensure products reach the market with the right quality and at the right time.

What we offer?

• A key quality role with significant responsibility and impact.
• International collaboration across manufacturing sites and partners.
• A high degree of independence and flexibility.
• Opportunities for professional growth and development.
• Hybrid working model and flexible working hours.
• Attractive compensation and benefits package – details depend on job location.

Job location

Odense (DK) or Warsaw (PL).

Why should you join Orifarm?

At Orifarm, we are united by a shared purpose: improving access to affordable medicine for the people who need it. Founded in Odense in 1994 by Birgitte & Hans Bøgh-Sørensen, we have built our business on challenging conventional thinking to make affordable high-quality pharmaceuticals more accessible across Europe. Rather than developing new medicines, we focus on finding smarter ways to bring existing treatments to patients, creating value for pharmacies, healthcare systems, and society.

We live by the mindset Challenge Accepted. It reflects our explorer spirit and can-do attitude, where challenges are perceived as opportunities. We encourage people to ask questions, challenge assumptions, and take ownership. Across teams, functions, and markets, you will find a collaborative and supportive culture built on trust, respect, and a flat hierarchy where everyone has a voice and direct access to decision-makers.

When you join Orifarm, you will be empowered to make a real impact from day one. We offer autonomy and great opportunities for career advancement, enabling our employees to shape their professional development. We value flexibility and provide a hybrid work model with the possibility of working from home two days a week.

We invite you to join Orifarm, if you are curious, ambitious, and accept the challenge of bringing better deals of medicine to millions.

At Orifarm, we welcome people from all backgrounds, recognizing that the best outcomes come from a diverse and inclusive work environment. Our commitment is to create an environment where different perspectives and skills drive innovation and contribute to a sustainable future. By creating such an environment, we are confident that we can achieve better results together.