J&J Family of Companies SENIOR QA SCIENTIST in Petaling Jaya, Malaysia
Part A: Overall Responsibility
Provide overall leadership for Quality System team activities, implemented from product development through to commercialization and distribution, in the manner that complies with National Pharmaceutical Control Bureau (NPCB) and Johnson & Johnson corporate quality standards.
Part B: Principal Responsibility
- Practice Global Leadership Profile (Max. of 8 bullet points)
• Integrity and Credo-based Actions
• Strategic Thinking
• Big Picture Orientation with Attention to Detail
• Organization and Talent Development
• Intellectual Curiosity
• Collaboration and Teaming
• Sense of Urgency
• Prudent Risk Taking
• Self-Awareness and Adaptability
• Result and Performance Driven
- Quality and Compliance Responsibilities
• To develop, implement, maintain and continuously improve quality systems that support development, manufacturing and release of product in order to meet standards, regulations and customer requirements.
• Maintains the quality systems’ readiness for inspection/audit.
• Support on mock field action, mock audit, QScan whenever necessary.
• To lead in plant performance management review preparation and other quality review meetings
• To administer and management of local application such as:
• PrintDoc System (electronic batch record management)
• E-Standard System (electronic packaging standard reference management)
• To conduct gap analysis and deploy regional and global standards cascaded down from the enterprise to the local site
- Documentation Control Responsibilities
• To develop, implement, maintain and continuously improve documentation systems provides assurance that quality related activities are carried out exactly the way they have been planned and approved.
• To ensure documents are developed, prepared, approved and distributed in a controlled manner.
• To ensure all levels of documentation are integrated to form a comprehensive and cohesive documentation network via a system of cross-referencing.
• To ensure batch record usage are controlled with serial number, reconciled and investigate for any missing records, with the support of electronic publishing tools.
• To track documentation status and to ensure timely revision or closure
- Change Control and System Compliance Responsibilities
• To coordinate the local and regional change control management
• To conduct change control application training to end users
• To administer Symphony GCC and GSS system
• To support the roll out of global initiative for local deployment.
- Audit Management
• Manage the audit process and to involve in audit to suppliers and other audit related events.
• Ensure planned audits are achieved
• Develop and maintain the auditor pool
• To keep abreast of new technology, among other means, is by direct communication with other J&J Affiliates and Originating Company, have in-depth knowledge of products/raw material in order to provide technical support for new product introduction or profit improvement projects.
• Proactively pursue self-learning to complete the competency requirement as per Competency model.
• Be a team member.
• To ensure PDP cycle is observed for performance evaluation, training needs identification and analysis and training plan implementation.
- GMP and SHE (Safety Health and Environmental) compliance.
• Ensure team/division compliance to SHE and GMP
• To ensure work station are clean and orderly
Bachelor Degree in relevant field and related experience.
Johnson & Johnson Sdn. Bhd. (8275)