Quality Batch Reviewer

Title: Quality Batch Reviewer

Location: Sweden – fully remote

Duration: 6 - months

Commitment: 30 – 40 FTE

Company Overview

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.

If you are interested in learning more, please reach out to Sweetness Zono at Apsida Life Science:

[email protected]

www.apsida.co.uk

+44 (0) 744 134 2281

www.apsida.co.uk

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