Johnson & Johnson Careers
Plant Quality Supervisor/Associate Manager
Petaling Jaya, Selangor
Requisition ID: 1805656992W
Subject Matter Expert for finished goods production Quality& Compliance for J&J Malaysia plant. Ensure all projects related to FG (NPD, Quality improvement) are executed and validated in compliance with cGMP and J&J policy. Ensured all projects executed are well documented and ensure execution in the manner meeting cGMP, Health, Safety and Environmental and corporate quality standards. Responsible for finished goods product releases from J&J Plant.
- To ensure Quality & Compliance program are executed and conforming to established specifications and procedures.
- Ensure completeness of documentation prior to release of FG under NPD, cost / quality compliance project with complete Authorization for Product Release (APR) and meeting quality requirement.
- Responsible for overall batch record management compliance and product release on timely manner.
- To ensure Investigation (INV) related to FG completed before UD (Usage Decision) made in SAP system.
- To participate in audit readiness and Internal audit.
- Ensure management of Retain sample Program in compliance with requirement.
- To ensure OSI yearly re-certification, QC inspector Program and annual GMP training carried out according to define frequency.
- Responsible in ensure plant shutdown execution in compliance of GMP requirements.
- Management of batch record, ensure reconciliation on monthly basis.
- To ensure that specifications are available, maintained and current
- To ensure compliance to SOP requirements for specification and documentation.
- Implement, coordinates and/or execute development and deployment of OGSM; defines and aligns quality dashboards and scorecards and end to end Metrics Management.
- Coordinate the Quality NPD/NPI processes to ensure consistency of execution
- Supports deployment of change management programs for the site.
- Key contact from MAKE Q&C in new product pipeline, and contributes to the reliability assessment plan for the product design.
- Tracking for Quality related Cost Improvement and Quality project (Innovation Lab, Reliability Room).
- Capability analysis and capacity/resource planning of plant Q&C.
- Candidate must possess at least Bachelor's Degree/Post Graduate Diploma/Professional Degree in Engineering (Bioengineering/Biomedical), Biology, BioTechnology or equivalent.
- At least 5 Year(s) of working experience in the related field is required for this position.
- Knowledge of GMP
- Preferably Senior Executive specialized in Manufacturing/Production Operations or equivalent.
Johnson & Johnson Sdn. Bhd. (8275)