QA Manager

Roles and Responsibilities

• Develop and manage company's GLP analytical laboratory quality systems to ensure GLP compliance including equipments, protocols, raw data and reports.
• Develop, implement and update company's quality system as applicable.
• Develop and maintain a document control system for document review, approval and archiving activities.
• Assist with cGMP batch record review and release.
• Develop and maintain equipment qualification protocols, calibration and maintenance records, and maintain equipment history files.
• Manage external audit program and perform QA audits of external vendors to ensure all activities follow related regulatory guidelines and manage any potential compliance risks.

Qualifications

• Demonstrate knowledge and experiences in establishment and maintain a good quality system for GLP analytical lab, experience with analytical QC is a plus.
• Demonstrated quality experience with injectable pharmaceutical product development.

• Demonstrated audit conduct experience is required.
• Experience of managing GMP manufacturing and analytical suppliers on quality and compliance.
• Great attention to details.
• Strong analytical and writing skills to identify issues, solve problems and document them appropriately.

Experience

• 5 years of quality experience managing the GLP analytical lab
• Auditing experience is required.

• Quality experience in pharmaceutical development