At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

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Job Description

• Perform market release activities in accordance with applicable regulations and internal quality requirements.
• Perform GSP internal audit management and support LOC internal and external audits, regulatory inspections, and follow-up actions to ensure timely closure of observations.
• Perform GSP quality risk management and support product quality risk assessment, issue escalation, and mitigation activities.
• Perform GSP quality system management, including related SOP/WIs management, guide and monitor the activities to ensure its effective operation.
• Perform quality management of GSP computer systems per J&J standards and GSP regulation requirement, and support GxP-related computerized systems upgrades, validation, and process implementation activities.
• Perform GSP licenses management, including license change application，communication with local health authorities.
• Support digitalization initiatives and quality system transformation projects like process optimization, system enhancement, data analysis, automation opportunities identification, and deployment of digital solutions to improve operational efficiency and compliance effectiveness.
• Drive continuous improvement initiatives to enhance quality system effectiveness, operational efficiency, and regulatory compliance.
• Perform other duties as assigned.

Required Qualification and Core Competencies

• Licensed pharmacist is mandatory.
• A bachelor's degree or higher in pharmacy, medicine, biochemistry or a related field is required.
• ≥3 years’ experience in the Pharmaceutical or related industry is preferred, ideally with a mix of Quality and Compliance (GxP), Distribution Warehouse management. Quality and Compliance experience is essential.
• Demonstrates strong written and verbal communication skills in both the local language and English.
• Expert knowledge of Microsoft software and presentation.
• Strategic thinking is required, with a focus on process improvement and optimization.
• Demonstrates strong pharmaceutical products and project management skills, with the ability to manage multiple tasks. Understanding of pharmaceutical product development, qualification, manufacturing, packaging, validation, testing, release and distribution processes. Up-to-date knowledge of relevant pharmaceutical legislation and GxP.

Preferred Skills:

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

Required Skills:

Preferred Skills: