
Fulfilling Career in Quality Assurance
1 week ago
Unlock a fulfilling career in quality assurance with our esteemed organization.
We are seeking a Quality Specialist to join our team, responsible for ensuring the highest standards of quality and compliance in our cell and gene therapy manufacturing processes.
As a Quality Specialist, you will be the champion of quality, driving process improvements and ensuring adherence to regulatory requirements.
Key Responsibilities:
- Initiate, investigate, and close deviations, and manage CAPA processes including effectiveness checks.
- Review, assess, and manage change controls related to materials, equipment, processes, and documentation.
- Perform thorough review of executed batch manufacturing records, critical logbooks, and associated documentation.
- Provide real-time QA support on the manufacturing floor during production, aseptic operations, and changeovers.
Requirements:
- Bachelor's or Master's in Life Sciences, Biotechnology, Pharmacy or equivalent.
- 3–5 years of GMP QA/Quality experience, preferably in Cell & Gene Therapy, Biologics, or ATMP manufacturing.
- Strong knowledge of cGMP, GDP, FDA/EMA standards, PIC/S, ICH Q7/Q9, Annex 1, data integrity principles.
- Proficiency with quality systems (deviation, CAPA, change control, document control, batch release etc).
- Excellent communication, analytical, problem‐solving, and collaborative skills.
Benefits:
- A challenging and rewarding role in a fast-paced industry.
- The opportunity to work with a talented team of professionals.
- Professional development and growth opportunities.
Join us as we strive for excellence in quality and innovation
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