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.
Remote Work :
No
Employment Type :
Contract