QA Specialist
Hydrogen Group ·www.hydrogengroup.com
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🔹 Responsibilities:
• Review executed batch records and supporting documentation for completeness, accuracy, and compliance
• Support product release activities and ensure adherence to cGMP, GDP, and ALCOA+ principles
• Review deviations impacting batch quality and assist with CAPA activities
• Maintain quality documentation and support audit and inspection readiness
• Identify process improvement opportunities and contribute to quality initiatives
🔹 Qualifications:
• Bachelor's degree in a scientific discipline preferred (or equivalent experience)
• 2–4 years of QA experience in a GMP-regulated environment
• Experience reviewing batch records and supporting product release activities
• Working knowledge of FDA, EMA, and cGMP requirements
• Familiarity with quality systems including Deviations, CAPA, Change Control, and Document Control
• Strong attention to detail, organizational skills, and documentation practices
🔹 Ideal Candidate:
✔ Experience in pharmaceutical, biotechnology, manufacturing, or other regulated industries
✔ Strong understanding of quality systems and compliance requirements
✔ Ability to work independently and manage priorities effectively
✔ Commitment to quality, integrity, and continuous improvement
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