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documentation ich guidelines qms cgmp gdp📋 Description
- Perform quality checks during manufacturing, filling, and packaging (weights, seal, line clearance)
- Document inspections per GDP and procedures
- Assist in the review of executed batch records for completeness and accuracy
- Support QA oversight of equipment setup and clearance activities
- Participate in deviation documentation and investigations
- Follow procedures to ensure compliance with 21 CFR Parts 210/211, ICH guidelines, and QMS
🎯 Requirements
- High School Diploma or equivalent
- 0-2 years of experience in QA, manufacturing, or regulated industry
- Basic understanding of cGMP and regulatory requirements
- Proficiency with Microsoft Office (Word, Excel, PowerPoint)
- Strong attention to detail, communication, and organizational skills
- Ability to work in controlled environments with gowning/PPE; stand for long periods
🎁 Benefits
- Competitive compensation with base salary and annual bonus
- Flexible PTO, holidays, and parental leave
- Generous benefits: healthcare, HSA match, 401k match, life and disability insurance
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