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Katalyst Healthcare's & Life Sciences (Katalyst HLS) is a Global Contract Research Organisation that provides End-to-End Clinical Research Services for Healthcare and Life Sciences companies globally. At Katalyst HLS offers ICH-GCP compliant clinical trial services from Phase I–IV in all key therapeutic areas to support clinical development and research requirements and also provides validation, quality and regulatory services for Pharma/Bio-Pharma/Medical Device industries. Services:- Clinical Trial Management- Clinical Data Management- Biostatistics & Statistical Programming- Medical Writing- Pharmacovigilance- Quality and Regulatory Affairs- GMP, GLP and GCP Validations- Manufacturing Process Validations- Equipments & Instruments Validations- Computer Systems Validations- Human Resourcing
Join a pioneering biotech company dedicated to advancing viro-immunotherapies and improving patient quality of life globally.
As a Quality Assurance Specialist at our client's innovative facility, you'll play a crucial role in upholding the integrity of groundbreaking therapies that have far-reaching impacts.
Impact patient lives by ensuring the highest quality in therapeutic development.
Contribute to groundbreaking work in viral, genetic, and cell-based therapies.
Competitive salary commensurate with experience and qualifications.
Robust benefits package including health, dental, life insurance, and a Simple IRA with employer match.
Professional growth in a dynamic and supportive environment.
Requirements:
Implement QA strategies and support GxP inspection readiness.
Perform audits ensuring compliance with regulatory standards.
Monitor and enhance laboratory quality assurance practices.
Develop compliance-related metrics and provide QA support across departments.
Manage training records and support both internal and external audits.
Hold a Bachelor's degree in a science-related field.
Expertise in GxP, GLP, GCP, and ISO standards.
Experience in a regulatory QA environment for at least 5 years.
Skills in data review and process audits are crucial.