Senior Engineer, Source Quality

Description

Responsible for assigned Japan Direct Materials (DM) suppliers to enhance and strengthen robustness of suppliers' quality systems and processes to prevent & eliminate risk of quality issues in J&J products for supporting business continuity.

The role shall be focused on management of Dr Cilabo supplier base.

Direct Material Supplier Audit

• Conduct periodic chemical, package supplier and distributor audits based on the Global Consumer Health standard procedures and issue supplier audit report to applicable system on time.
• Write, manage Supplier Corrective Action Plan (SCAP) closure follow up by closely working with suppliers to review, collect evidence for the identified action items and upload to applicable systems timely.
• Support new supplier qualification audits based on the business needs.
• Ensure that every Japan suppliers has established and effectively maintained quality management system and quality practices that meet J&J requirements.

Direct Material Supplier Issue Handling

• Co-ordinate the investigation of non-conformance, evaluate causal drivers and determine CAPA actions.

Participate in final investigation decision for non-conforming materials/products.
• Drive supplier investigation based on root cause analysis tools and review/ guide supplier until the root cause is effectively analyzed and correction/ corrective action is properly set up.
• Regular follow up on all due action items to meet on-time closure in the system and continuous effective monitoring for completed supplier action items.
• Lead supplier driven CAPA if the issue is critical or repeated issues and monitor effectiveness of CAPA actions.
• Support complaint handling investigation process and timely response in co-ordination with EM

DM Supplier Reliability and Continuous Improvement

• Lead in regional and(or) local supplier improvement projects including maturity assessments and other proactive initiatives.
• Support Raw Material Center (RMC) / Global Packaging (GP) / Technical Support and Governance for new supplier/ material qualification.

• Education Requirement: Bachelor or Master of Science, preferably Chemistry, Pharmaceutical, Biological Science or Engineering studies.
• Minimum Experience: Four years of Quality or related work experience in cosmetic/pharmaceutical manufacturing.
• Knowledge of Microbiology in Cosmetic/Pharmaceutical quality assurance
• Additional experience in Engineering/Technical and /or Operations is preferred.
• Exposure to regulators audits and regulatory requirements.