Quality Control Lead

Johnson & Johnson is looking for their next Quality Control Lead. This role will provide leadership, key direction and oversight to Quality Control Laboratory and ensure the laboratory operation is in accordance to Good Laboratory Practice, Good Manufacturing Practice and Environment, Health & Safety requirement accordingly to Company Quality Policy Standards and applicable Regulatory Requirements. This role is based at our manufacturing plant at Jalan Tandang, Petaling Jaya. Principal Responsibility Practice Global Leadership Profile • Strategic Thinking • Intellectual Curiosity • Sense of Urgency • Prudent Risk Taking • Self Awareness and Adaptability • Result and Performance Driven QUALITY AND COMPLIANCE RESPONSIBILITIES 1. Quality Control (QC) Laboratories To lead and manage the entire Quality Control laboratory operation in accordance to GMP, GLP and Quality System Requirements. Act as subject matter expert for the QC Laboratories. Ensure QC programs are executed as per requirements and support in performing analytical/microbiological analysis for Raw Material, WIP Bulk, Finished Good and environmental samples. Implement Quality System that ensures quality data review and timely material release. To ensure that lab equipment and facilities is qualified, calibrated, and maintained as per GLP requirements. Ensure appropriate change management and deliverables executed including test method validation, analyst and equipment qualification to assure accuracy in results generated to support any changes and new product launch. Troubleshoots and solves high risk and high complexity issues, using experience, ingenuity, and creativity to implement solutions across a wide range of root causes. Accountable for material disposition and compliance decisions of QC programs. To ensure GLP and data integrity fully adhere by lab analysts. Assures compliance with all local government regulatory requirements and J&J requirements related to things such as sampling plans, design control, and quality systems. Ensure audit readiness in entire Quality Control Laboratory in both internal and external audits. Support in the internal audit program for the site. Responsible in the overall management of Quality Control Laboratory housekeeping and safety. Ensure proper management of chemicals, waste and adherence to safety requirements. Ensure lab records management and control (which includes reconciliation, storage, protection, retrieval, retention and disposition of records) are in place to provide evidence of conformity to requirement To ensure that procedures, work instructions, specifications, forms and relevant records are available, maintained and current. Responsible in the management of indirect suppliers including external laboratories that are engaged by the lab to ensure compliance to requirements. 2. BUILDS STRONG NETWORK AND COLLABORATION Provides overview or detailed communications to Q&C and cross-functional leadership on QC Lab performance status of initiatives and issues. This communication occurs at a plant-level, and at a regional-level. Build strong interdependent and truly partnership with the local Operation and cross functional team. Collaborate with other counterparts to drive continuous improvement in lab and lead/support in regional initiatives 3. PROMOTE CONTINUES IMPROVEMENT Organizes, plans, leads, and manages quality related projects in alignment with company goals. Lead the design and implementation of safety, Q&C, customer service and cost improvement programs and initiatives. Innovate solutions to significant quality system gaps and lead continuous improvement projects. Support in JJPS initiatives, plant OGSM and regional / global initiatives. 4. DRIVES TALENT DEVELOPMENT Facilitates the development and training of immediate staff. Ensures a strong pipeline of talent for leadership roles and critical positions. Partners with industry leaders, and sector/enterprise senior technical stakeholders, to develop and implement best practices and improvement opportunities. Ensure entire Quality Control Laboratory analyst are trained and qualified to perform laboratory task and testing effectively and efficiently. 5. OVERSIGHT CAPEX AND OPEX Manage the budget allocation for Quality Control Laboratory and ensure laboratory inventory is enough to avoid interruption in daily laboratory operation. Qualifications Bachelor Degree in Science related field, preferable in Chemistry, Microbiology and equivalent A minimum of 5-7 years of GLP experience in a QC role, in either Pharmaceutical, Medical Device, OTC Drug, Cosmetic and/or Food and Dietary Supplements Production with strong technical skills and knowledge in Chemical/Analytical and Microbiological Testing. Experience in Good Laboratory Practices and Quality Management System including Handling of Lab Investigations, Nonconformances and CAPA, Root Cause Analysis, Good Hygiene Practices, Data Integrity and good understanding of safety, Halal, cGMP, ISO9001 and regulatory requirements. Good in technical writing skills and root cause problem solving. Primary Location Malaysia-Selangor-Petaling Jaya- Organization Johnson & Johnson Sdn. Bhd. (8275) Job Function Quality Requisition ID 2206047741W