QA Operation

Nusantara Prime Consulting; Singapore; On-site; SGD 20,000 - 60,000; Full time

Job summary

A prominent biopharmaceutical consulting firm in Singapore is seeking a Quality Assurance Professional to oversee manufacturing and testing activities. The ideal candidate should have a bachelor’s degree and 3-5 years of QA experience in the biopharma industry, familiar with regulatory requirements. This position is a 6-12 months contract based in Tuas, with company transport provided.

Benefits

Company transport provided

Qualifications

• 3-5 years of QA experience in Biopharma or Pharmaceuticals required.
• Familiarity with FDA, EMEA, and PICS GMP requirements essential.
• Experience in biopharma commercial supply preferred.

Responsibilities

• Oversee routine quality control for on-site GMP production.
• Contribute to the establishment of an effective quality system.
• Provide quality oversight for validation and re-qualification activities.

Skills

Quality control

Regulatory compliance

Cross-functional communication

Conflict management

Logical thinking

Education

Bachelor’s degree in Biologics, Pharmacy, Pharmaceutical Engineering, or related field

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

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

Responsibilities

• Oversee routine quality control for 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
• Accountable for QA Review of all Qualification and Validation protocols and reports, including computer system validation.
• Ensures that the data integrity of all documentation and electronic data complies to all application regulations and SOP requirements
• Participate in site operational readiness programs, including self‑inspection and data integrity surveillance for GMP and client audits.
• Manage quality events, including deviations, change controls, CAPA, and lab investigations etc.
• Carry out additional tasks as assigned by leadership.

About You

• Bachelor’s degree or higher in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or other relevant fields.
• At least 3-5 years of relevant QA experience in Biopharma or Pharmaceuticals
• 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.
• 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.

Based in Tuas, company transport provided.

6 - 12 months contract.