QA Operation

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 1-3 years of relevant QA experience in Biopharma or Pharmaceuticals for Junior role & 3-5 years of experience for Senior role.
• 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.

Contract Period: 12 months