发布 Apr 14, 2025 125 查看 Report Job
You will be responsible for ensuring that all products meet internal and external quality standards before they reach our customers. You will support the implementation, maintenance, and continuous improvement of the Quality Management System (QMS) in compliance with GMP, regulatory, and company requirements.
Key Responsibilities
• Ensure compliance with GMP, regulatory requirements, and company quality standards.
• Review and approve batch manufacturing and packaging records.
• Perform deviation, CAPA, and change control assessments.
• Participate in internal audits and support external regulatory inspections.
• Provide QA oversight during production, packaging, and warehouse operations.
• Review and maintain quality documentation such as SOPs, protocols, and reports.
• Support validation activities including cleaning, process, and equipment validation.
• Ensure timely QA support for product release, complaints, and recalls.
• Train staff on quality systems, GMP, and regulatory expectations.
• Monitor trends and contribute to quality improvement initiatives.
Qualifications
• Bachelor’s degree in Pharmacy, Chemistry, Biology, or related field.
• 2–5 years of experience in pharmaceutical QA or a related field.
• In-depth knowledge of cGMP regulations (FDA, EMA, ICH).
• Experience with quality systems, batch record review, and deviation management.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication.
Desirable Skills
• Experience with quality audits and regulatory inspections.
• Familiarity with electronic QMS platforms.
• Knowledge of pharmaceutical manufacturing and packaging processes.
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