Quality Assurance Associate

The Role

Responsibilities

• Ensure each batch document is thoroughly reviewed for compliance prior to releasing batch to the market
• Ensure each complaint is properly reviewed and investigated, and closed in timely manner following with Global Quality Policy and applicable Regulatory requirements
• Perform trend analysis of complaints and waste/scraps and work with Manufacturing team to implement continuous improvement/complaint & waste/scrap reduction
• Ensure proper root cause analysis is performed when a trend of Customer Complaint is received or a deviation is reported in MPI database
• Ensure proper root cause analysis in Non-Conformance Reports (NCRs) and Manufacturing Process Improvements (MPIs) to continuously improve Right First Time performance
• Manage Manufacturing Non-Conformance Reports (NCRs) and Manufacturing Process Improvements (MPIs) to ensure they are adequately written, closed in timely manner and all associated CAPAs are implemented
• Provide inputs for Monthly Indicators, Management Review, and Annual Product Review
• Support Release Department as needed.

Key Requirements

• A Tertiary degree in Pharmacy, Science, Engineering or related fields
• Proven experience in Sterile Manufacturing and/or Quality Assurance processes
• Strong understanding of regulatory requirements and quality standards
• Outstanding attention to detail and analytical skills
• Excellent communication and teamwork abilities
• Proficiency in quality management software and tools
• Ability to strictly adhere to deadlines and manage multiple tasks simultaneously
• Outstanding communication and collaboration skills.

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Equal Employment Opportunity