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QA Senior Specialist - Manufacturing QA
Job Summary
Responsible for overseeing manufacturing and testing 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.
- Review and approve manufacturing and testing-related documents.
- Authorize the release of facilities, utilities, equipment, and instruments for production use.
- Manage quality events, including deviations, change controls, CAPA, and lab investigations etc.
- Support both internal and external audits.
- Responsible for batch documentation review.
- Carry out additional tasks as assigned by leadership.
Qualifications
- Bachelor's degree or higher in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or other relevant fields.
- At least 8-10 years of experience in production and/or quality management (QA/QC), with a minimum of 5 years in production QA.
- 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.
- 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.
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