GxP QA Specialist: Batch Release & Compliance

rhythmpharmaceuticals; Amsterdam; Hybrid; EUR 65,000 - 90,000; Full time

Job summary

Rhythm Pharmaceuticals is seeking a QA Specialist to support GMP/GDP compliance during manufacture and distribution of clinical and commercial products at our Netherlands office. You will manage batch release readiness, document controls, and quality records, ensuring inspection readiness and continuous improvement.

Reporting to the Senior Manager Quality Assurance/QP, you will collaborate with QPs, RPs, and cross-functional teams across Technical Operations, Regulatory, Supply Chain, and

Qualifications

• Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Biotechnology, Chemistry, or a related discipline.
• 3+ years in pharmaceutical QA, manufacturing, document control, or GMP/GDP environment; or 2+ years with a Master’s/advanced degree.
• Good GMP/GDP knowledge; familiarity with QA systems and batch documentation.

Responsibilities

• Coordinate batch release readiness and batch release documentation for IMPs and commercial products.
• Compile batch records and ensure documentation is complete and traceable.
• Perform initial QA checks of batch documentation for completeness and compliance.
• Manage GMP/GDP documentation routing and filing in electronic systems.
• Serve as main point of contact for documentation requests from external partners.
• Track deviations, CAPAs, change controls, temperature excursions and follow up actions.

Skills

GxP knowledge

QA documentation

Batch release coordination

Education

Bachelor’s degree in Pharmacy or related field

Tools

eQMS

EDMS

ERP systems

Job description

Rhythm Pharmaceuticals is seeking a QA Specialist to support GMP/GDP compliance during manufacture and distribution of clinical and commercial products at our Netherlands office. You will manage batch release readiness, document controls, and quality records, ensuring inspection readiness and continuous improvement.

Reporting to the Senior Manager Quality Assurance/QP, you will collaborate with QPs, RPs, and cross-functional teams across Technical Operations, Regulatory, Supply Chain, and