Manufacturing QA Senior Specialist

WUXI XDC SINGAPORE PRIVATE LIMITED; Singapore; On-site; SGD 90,000 - 120,000; Full time

Job summary

A biopharmaceutical company in Singapore is seeking a professional to oversee manufacturing and testing activities ensuring compliance with internal and regulatory requirements. The ideal candidate will have a Bachelor's degree in a relevant field and 8-10 years of experience in production and quality management, including GMP knowledge. Responsibilities include managing production activities, quality oversight, and supporting audits. Strong communication, conflict management, and collaboration skills are essential for this role.

Qualifications

• 8-10 years of experience in production and/or quality management (QA/QC), with minimum 8 years in production QA.
• Familiar with FDA, EMEA, and PICS GMP requirements.
• Experience with biopharma commercial supply preferred.

Responsibilities

• Oversee on-site GMP production and testing.
• Contribute to the quality system establishment and operation.
• Manage quality events including deviations and CAPA.

Skills

Quality oversight

Cross-functional communication

Conflict management

Strong learning ability

Education

Bachelor's degree or higher in Biologics, Pharmacy, Pharmaceutical Engineering, or Bioengineering

Tools

Microsoft Word

Excel

PowerPoint

Job description

Job Summary

Responsible for overseeing manufacturing and testing activities, ensuring compliance with internal procedures and regulatory requirements.

Responsibilities

• Oversee on-site GMP production and testing, ensuring all GMP activities are executed in strict adherence to company procedures.
• Contribute to the establishment of an effective quality system and ensure its efficient operation across all GMP functions and processes in daily operations.
• Provide quality oversight for validation and re-qualification activities, ensuring validation status is consistently maintained.
• Review and approve manufacturing and testing-related documents.
• Authorize the release of facilities, utilities, equipment, and instruments for production use.
• Manage quality events, including deviations, change controls, CAPA, and lab investigations etc.
• Support both internal and external audits.
• Responsible for batch documentation review.
• Carry out additional tasks as assigned by leadership.

Qualifications

• Bachelor's degree or higher in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or other relevant fields.
• 8-10 years of experience in production and/or quality management (QA/QC), with a minimum of 8 years in production QA.
• Familiar with FDA, EMEA, and PICS GMP requirements.
• Knowledgeable in biological product manufacturing and related quality control requirements.
• Experience in biopharma commercial supply is preferred.
• Experience with a new site start-up is preferred.
• ADC manufacturing and quality management experience is a plus.
• Proficient in English listening, speaking, reading, and writing.
• Skilled in Microsoft Word, Excel, PowerPoint, etc.
• Strong learning ability.
• Excellent cross-functional communication and collaboration skills.
• Strong logical thinking and conflict management abilities.
• Demonstrates strong ownership.