
Quality Assurance Specialist
1 dia atrás
Job Overview:
A Quality Assurance Specialist plays a vital role in ensuring the excellence of products by developing, implementing, and maintaining quality systems. This encompasses creating and reviewing Standard Operating Procedures, examining and approving raw material specifications, and investigating out-of-specification results.
Key Responsibilities:
- Develop, implement, and maintain quality control systems
- Prepare and review Quality Control Procedures (QCPs)
- Examine and approve raw material specifications
- Investigate non-conforming results
- Conduct change control and deviation investigations
- Prepare and review batch records
- Review certificates of analysis, including raw data verification
- Support stability studies
Requirements:
- Bachelor's degree in Industrial Chemistry, Pharmacy, or Chemical Engineering
- Previous experience in quality assurance in a regulated industry
- Proficiency in Microsoft Office (Word, Excel, PowerPoint, and Outlook)
- Knowledge of technology transfer in third-party manufacturing
- Strong knowledge of Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP)
- Knowledge of regulatory requirements for pharmaceutical products, including stability data
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