Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Responsibilities:
- Develop, implement, and maintain quality systems and procedures in compliance with FDA, EMA, and cGMP regulations.
- Support deviation investigations, CAPAs, and change control activities.
- Review and approve manufacturing and quality documentation including SOPs, batch records, and protocols.
- Participate in internal audits, risk assessments, and inspection readiness efforts
- Collaborate with cross-functional teams (QA, QC, Manufacturing, Validation, Engineering) to ensure product quality and compliance.
- Lead continuous improvement initiatives for quality system enhancement.
Requirements:
- 8+ years of quality engineering experience in pharma or biotech.
- Strong understanding of FDA regulations, ICH Q8-Q10, and cGMP standards.
- Hands-on experience with CAPA, deviation management, and quality documentation.
- Excellent written and verbal communication skills.
- Strong problem-solving and analytical mindset.