Quality Batch Reviewer

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 focused on developing novel, disease-modifying therapeutics for neurodegenerative diseases and neurodevelopmental disorders.

Responsibilities:

• Executed Batch Record Review: Independently review and approve executed GMP batch records for Drug Substance (DS) and/or Drug Product (DP) from the Swedish manufacturing partner.
• Batch Disposition & Release Support: Evaluate batch records, certificates of analysis (CoAs), and supporting quality data to enable timely batch disposition and release decisions.
• Labelling & Documentation Review: Review and approve product labelling, labels, and associated packaging/labeling documentation in accordance with regulatory requirements and sponsor specifications.
• Deviation & Exception Handling: Actively follow up on deviations, out-of-specification (OOS), investigation reports, and documentation errors directly with the contract manufacturer.
• Coverage & Continuity: Serve as a reliable backup to the Lead Batch Reviewer during holidays, leaves of absence, or peak workload periods.
• Cross-Border Communication: Summarize findings, quality metrics, and risk assessments clearly and concisely in English for presentation to the US-based Quality Leadership team.

Qualifications:

• Native or fluent Swedish (written and spoken) combined with professional-level written and spoken English.
• GMP Expertise: Hands-on, practical experience reviewing and approving executed GMP batch records (Drug Substance and/or Drug Product).
• Batch Release Experience: Proven background supporting batch disposition and release activities under EU GMP guidelines.
• Level & Autonomy: Manager-level experience with demonstrated ability to make sound, independent quality approval decisions (this role is tailored for a manager-level consultant, rather than Director-level).
• Regulatory Knowledge: Deep understanding of EU GMP directives, guidelines, and quality standards for clinical and commercial biopharmaceuticals.
• CDMO/CMO Oversight: Direct experience in sponsor-side management and quality oversight of contract manufacturers and development partners.
• QP Knowledge: Qualified Person (QP) eligibility or hands-on experience supporting QP certification processes.

Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) & Pretoria (South Africa) that is dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost-effective, high-quality, and trusted recruitment service that puts the candidate journey at the heart of the recruitment process