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
