Our client is entering intoperformance qualification (PQ), a vital part of the quality assurance system, and is looking for a QA Advisor consultant to help with the quality review, run process simulations, help with documentation issues & schedules and consults on QA process.

Responsibilities include:

• Provides high level resolution of root cause and corrective action items
• Develops quality systems/procedures and provides QA guidance
• Contributes to the QA planning and risk assessment activities
• Leads or co-audits vendors, internal and external systems
• Conducts investigations of GMP related issues and creates corrective action plans
• Reviews Environmental monitoring and additional QC data
• Interprets regulatory authority regulations and guidelines to verify compliance
• Administers and maintains various Quality Management Systems, including change management, deviation management, document control, records management, and GXP training management
• Complies with all applicable policies regarding health, safety, and environmental policies

Posted On: Monday, January 30, 2023