Global QA Specialist – Product Launch & Transfers (Hybrid)

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

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.