Validation QA Specialist

WUXI XDC SINGAPORE PRIVATE LIMITED; Singapore; On-site; SGD 80,000 - 100,000; Full time

Job summary

A biopharmaceutical company in Singapore is seeking a Validation QA professional. The role involves overseeing manufacturing and testing activities, ensuring compliance with internal and regulatory requirements. Candidates should have a Bachelor's degree in relevant fields and 8-10 years of QA experience in the Biopharma industry. Proficiency in English and skills in Microsoft Office are essential. Strong communication and conflict management abilities are also required. Join us to contribute to the quality system within a dynamic team.

Qualifications

• 8-10 years of relevant QA experience in Biopharma or Pharmaceuticals industry.
• Familiar with FDA, EMEA, and PICS GMP requirements.
• Knowledgeable in biological product manufacturing and related quality control requirements.

Responsibilities

• Provide quality oversight for validation and re-qualification engineering activities.
• Review and approve GMP manufacturing and testing-related documents.
• Authorize the release of facilities, utilities, and equipment for GMP production use.

Skills

Quality oversight

Cross-functional communication

Conflict management

Learning ability

Education

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

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Job Description –Validation QA

Job Summary

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

Responsibilities

• Provide quality oversight for validation and re-qualification engineering activities, ensuring validation status is consistently maintained for related facilities and systems.
• Review and approve GMP manufacturing and testing-related documents.
• Authorize the release of facilities, utilities, equipment, instruments and automation systems for GMP production use.
• Oversee routine on-site GMP production, NPI related activities and testing, ensuring all GMP processes 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.
• Manage quality events, including deviations, change controls, CAPA, and lab investigations etc.
• Support both internal and external audits.
• 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 relevant QA experience in Biopharma or Pharmaceuticals industry.
• Familiar with FDA, EMEA, and PICS GMP requirements.
• Knowledgeable in biological product manufacturing and related quality control requirements.
• 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.