Job Description
- Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
- We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.
Job Description
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.
Additional Information
All your information will be kept confidential according to EEO guidelines.
Job Tags
Contract work, Immediate start,