GMP QA Specialist – Launch & Tech Transfer (Hybrid)

Orifarm; Odense; Hybrid; DKK 411,000 - 673,000; Full time

Benefits offered by this job

Hybrid working model

Flexible working hours

Job summary

Orifarm, a pharmaceutical company, seeks a QA Specialist to support product launches and technology transfers from a QA perspective. You will ensure GMP compliance and collaborate with CMOs and internal stakeholders to secure timely supply.

The role requires a degree in a scientific discipline, experience in GMP, and fluent English. You will review manufacturing docs, participate in change controls, and drive QA process improvements in a fast-paced, international environment.

Qualifications

• Bachelor's or Master's in a scientific discipline.
• Experience in QA/QC or GMP environments.
• Knowledge of EU GMP requirements.
• Ability to manage multiple priorities and work independently.
• Fluent English communication.

Responsibilities

• Provide QA support for product launches and tech transfers.
• Collaborate with CMOs and internal stakeholders.
• Ensure documents comply with GMP, procedures, specifications.
• Review and approve Master Batch Records and Batch Journals.
• Identify and escalate quality/compliance issues.
• Participate in change controls, deviations, and risk assessments.
• Drive continuous improvement of QA processes.

Skills

QA/QC experience

GMP knowledge

Cross-functional collaboration

Education

Bachelor's or Master’s in science

Job description

Orifarm, a pharmaceutical company, seeks a QA Specialist to support product launches and technology transfers from a QA perspective. You will ensure GMP compliance and collaborate with CMOs and internal stakeholders to secure timely supply.

The role requires a degree in a scientific discipline, experience in GMP, and fluent English. You will review manufacturing docs, participate in change controls, and drive QA process improvements in a fast-paced, international environment.