Manufacturing QA Specialist - #1130635

Job Summary

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

Responsibilities

●        Oversee 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.

●        8-10 years of experience in production and/or quality management (QA/QC), with a minimum of 8 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.