QA Specialist - GMP & Compliance Expert

ALK-Abello; Isterød; On-site; DKK 350,000 - 450,000; Full time

Benefits offered by this job

Tailored training

Competitive salary

Comprehensive benefits

Job summary

ALK-Abello in Denmark is seeking a Quality Assurance Specialist to ensure compliance with GMPs and contribute to quality assurance practices. The role involves performing Quality Assurance activities, managing APQR reports, and reviewing GMP technical reports.

The ideal candidate will hold a degree in Chemistry, Pharmacy, or Biology and possess at least 3 years' experience in the pharmaceutical industry. ALK offers tailored training, competitive benefits, and a collaborative work culture.

Qualifications

• Minimum of 3 years’ experience in the pharmaceutical/biotech industry.
• Fluent in English, both written and spoken.
• Experience with technology transfer projects and process validation.

Responsibilities

• Perform Quality Assurance activities associated with maintaining internal Quality Systems.
• Manage APQR reports and coordinate inputs from different Product Supply areas.
• Review GMP technical and validation reports.

Skills

Understanding of GMPs

Knowledge of regulations for sterile medicinal products

Fluent in English

Strong interpersonal skills

Proficiency with SAP

Education

Studies related to Chemistry, Pharmacy, Biology or equivalent

Job description

ALK-Abello in Denmark is seeking a Quality Assurance Specialist to ensure compliance with GMPs and contribute to quality assurance practices. The role involves performing Quality Assurance activities, managing APQR reports, and reviewing GMP technical reports.

The ideal candidate will hold a degree in Chemistry, Pharmacy, or Biology and possess at least 3 years' experience in the pharmaceutical industry. ALK offers tailored training, competitive benefits, and a collaborative work culture.