Senior GMP Batch Reviewer (Swedish/English)

Apsida Life Science; Danmark; On-site; SEK 850,000 - 1,150,000; Full time

Job summary

Apsida Life Science is currently partnering with a biopharmaceutical organisation seeking an experienced QA professional to lead GMP batch review, release support, and regulatory documentation for DS/DP.

The role requires hands-on review of CoAs, deviation handling, and independent quality approval decisions with EU GMP knowledge. You will also back up the Lead Batch Reviewer during peak workloads and communicate findings to the US-based Quality Leadership team in English.

Qualifications

• GMP expertise with hands-on review and approval of batch records.
• Experience supporting batch disposition and release under EU GMP.
• Manager-level autonomy with ability to make quality decisions.
• Deep understanding of EU GMP directives and quality standards.
• Direct experience with sponsor-side oversight of CMOs/CMOs.
• Qualified Person (QP) eligibility or support for QP certification.

Responsibilities

• Review GMP batch records for Drug Substance and/or Drug Product.
• Support batch disposition and release by evaluating CoAs and quality data.
• Review product labelling and related packaging/labeling documentation.
• Investigate deviations, OOS, and related investigation reports.
• Back up Lead Batch Reviewer during holidays or peak workload.
• Summarize findings and risk assessments in English for US QA leadership.

Skills

GMP expertise

Batch release

Manager-level experience

Regulatory knowledge

CDMO/CMO oversight

QP eligibility

Job description

Apsida Life Science is currently partnering with a biopharmaceutical organisation seeking an experienced QA professional to lead GMP batch review, release support, and regulatory documentation for DS/DP.

The role requires hands-on review of CoAs, deviation handling, and independent quality approval decisions with EU GMP knowledge. You will also back up the Lead Batch Reviewer during peak workloads and communicate findings to the US-based Quality Leadership team in English.