QA Operation
Summary
Oversee GMP production, testing, and validation for biopharma, ensuring compliance with regulations and internal procedures.
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