QA Engineer at DotWorld ensuring quality in SaaS products through testing and automation. Collaborating with development teams to maintain application reliability and quality.
About the role
- Biological QA Specialist ensuring GMP/GDP compliance for medicinal products. Leading quality strategy for global launches at an international pharmaceutical group.
Responsibilities
- Act as the Qualified Person for the GMP release of biological drug products (commercial and clinical trials).
- Supervise quality standards and production processes at external manufacturing sites.
- Manage a high volume of Change Controls, Deviations, CAPAs, and OOS.
- Review and approve Master Batch Records, analytical methods, validation protocols, and Quality Agreements.
- Serve as the primary point of contact for quality topics and coordinate batch recalls if necessary.
Requirements
- University Degree in Pharmacy (essential for QP status in Spain).
- At least 1 year of experience as a Qualified Person (or Deputy) specifically with biological products (e.g., monoclonal antibodies).
- 2-5 years in QA.
- Strong preference for candidates with prior experience in Manufacturing (Bioreactors) or Quality Control (QC).
- Proficiency in English and Spanish.
- Analytical, process-oriented and capable of managing complex dossiers.
Benefits
- Global Impact: Lead the quality strategy for major worldwide launches.
- Technical Depth: A role with significant responsibility in a specialized, fast-growing biological portfolio.
Job title
Job type
Experience level
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Not specified
Degree requirement
Location requirements
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