[Innovative Medicine] Senior Quality Specialist

About the role

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

What you'll do

• Ensure appropriate change control procedures are followed. Monitor change control status for timely closure and support issues related to COMET.
• Ensure appropriate quality event management procedures are followed. Monitor QEM status for timely closure and support issues related to COMET.
• Prepare quality metric data for QSMR and monthly review for change control and purchasing control. Keep related trackers up to date.
• Update and keep product list up to date on TruVault.
• Establish and revise LOC procedures in accordance with local GxP, CQM and J&J requirements for change control.
• Support internal audit and HA inspection for auditing and documentation. Support supplier qualification and document management.
• Manage the management of QA activities for imported products release from End to End, incoming inspection, sample shipment arrangement, release checklist preparation and so on.
• Ensure the redressing requirement from End to End, visual check against retention sample with approved artwork, confirming redressing artwork and preparing redressing instruction and so on.
• Oversee the new product introduction process including test method transfer, QC tests, change control management and master formula preparation.
• Establish Annual Product Quality Review in a timely manner.
• Ensure warehouse 3PL oversight and self inspection by periodic walk-through.
• Conduct supplier and distributor management.

Requirements

• At least 2 years' experience in the Pharmaceutical or related industry, ideally with a mix of Manufacturing / QA operations.
• Bachelor's degree in Pharmacy / Chemistry / Life Science / Microbiology or equivalent.
• Demonstrated experience in internal and external audits, regulatory inspections, Product Quality Complaint (PQC) handling, Nonconformance and Change Control management, document control, training management, batch release activities, and new product launch preparation.
• Strong organizational and time management skills, with the ability to effectively manage multiple priorities in a dynamic environment.
• Highly detail-oriented with a strong commitment to quality, accuracy, and timely execution of assigned responsibilities.
• Proactive and adaptable mindset, with the ability to effectively navigate change, assess risks, and respond to unexpected challenges.
• Strong interpersonal and collaboration skills, with a demonstrated ability to work effectively in cross-functional and multicultural teams.
• Understanding of pharmaceutical product development, qualification, manufacturing, packaging, validation, testing, release and distribution processes.
• Up-to-date knowledge of relevant pharmaceutical legislation and GxP including but not limited to GMP/GDP.
• Korea and English bilingual is preferable. At least, fluent English in both verbal and written.

Preferred qualifications

• Audit Management
• Business Behavior
• Coaching
• Compliance Management
• Continuous Improvement
• Data Analysis
• Detail-Oriented
• Goal Attainment
• Internal Controls
• Issue Escalation
• Problem Solving
• Process Oriented
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Standards
• Regulatory Environment

Benefits

자세한 사항은 홈페이지 참조