Q&C Specialist-2307005503W
Description




Who we are At Kenvue, part of the Johnson & Johnson Family of Companies, we believe there is extraordinary power in everyday care. Built on over a century of heritage and propelled forward by science, our iconic brands\xe2\x80\x94including NEUTROGENA\xc2\xae, AVEENO\xc2\xae, TYLENOL\xc2\xae, LISTERINE\xc2\xae, JOHNSON\xe2\x80\x99S\xc2\xae and BAND-AID\xc2\xae \xe2\x80\x94are category leaders trusted by millions of consumers who use our products to improve their daily lives. Our employees share a digital-first mindset, an approach to innovation grounded in deep human insights, and a commitment to continually earning a place for our products in consumers\xe2\x80\x99 hearts and homes.
What will you do Part A : Overall Responsibility Driving in proactive quality initiatives and ensure plant processes, practices and execution adhered to cGMP and company requirements. Key subject matter in Quality Assurance activities, processes and product releases including process controls, inspection and testing, intended to ensure effective product quality processes are in place and executed throughout lifecycle of product. Will receive technical guidance on complex problems, but independently determines and develops approaches and solutions. Work is usually well defined and is checked for progress and reviewed for accuracy upon completion. Part B : Principal Responsibility 1. Practice Global Leadership Profile

• Strategic Thinking
• Intellectual Curiosity
• Sense of Urgency
• Prudent Risk Taking
• Self Awareness and Adaptability
• Result and Performance Driven

2. Quality and Compliance Responsibilities

• Quality Inspection in shopfloor, perform process confirmation and overseeing the quality of the material, bulk, WIP and finished product and practice in production to ensure meeting requirements
• Involve in investigation of material and/or product quality issues and partnering with cross functional team in root cause problem solving
• Responsible for batch record review and support in product release on timely manner in order to meet regulatory and customer requirements.
• Support in Q&C deliverables in new product development which include document readiness, upload of documents and/or specifications in local computerized system, arrangement of FAI samples and tracking of FAI approval on timely manner.
• To support in all quality activities in shopfloor including in process inspection and initiatives to drive compliance and process improvement and robustness which includes global, regional and local strategic initiatives.
• To support end-to-end batch record management (including reconciliation, review, retrieval, retention, arrangement for scanning) as per requirements and support in timely FG release including CoA request for market affiliates).
• Responsible for overall standard reference management for FG and ensure accurate and timely phase in of new standard reference.
• Support in the INV & CAPA in investigation, retain sample pull out, inspection and execution of actions, verification and effectiveness monitoring.
• Support in the management of audit for the site which covers internal audits (self-assessments), JJRC audits, Health Authority audits and other external audits such as supplier audits in accordance to standardized process.
• Coordinate and support in shopfloor training and classroom training for office-based employees.
• Support on the OKR (objective key results) related projects and plant initiatives, MRA program and Shop Floor Proactive Quality Culture initiatives
• Administer local system for batch record management and standard reference management and support in the training and troubleshooting.
• To support in complaint investigation process and implementation of Corrective and Preventive Action items.

3. Documentation Control Responsibilities

• Ensure batch 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, COA and relevant records are available, maintained and current.

4. Self Development

• Proactively pursue self-learning
• Be a team member

Qualifications

What we are looking for Required Qualifications

• Bachelor\xe2\x80\x99s Degree in science related field and equivalent
• A minimum of 2-3 years of GMP experience in a QA role, in either Pharmaceutical, Medical Device, OTC Drug, Cosmetic and/or Food and Dietary Supplements Production. Fresh graduate are also encouraged to apply.

Desired Qualifications

• Experience in Quality Management System covering Production and Process Controls, Identification and Traceability, Handling of Nonconformances and CAPA, Root Cause Analysis, Good Hygiene Practices, Data Integrity and good understanding of Halal, cGMP, GDP, ISO9001 and regulatory requirements.
• Good proficiency in English and Malay in terms of communication and writing.
• Good in technical writing skills and root cause problem solving.

What\xe2\x80\x99s in it for you

• Competitive Benefit Package
• Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!
• Learning & Development Opportunities
• Employee Resource Groups

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.


Primary Location Asia Pacific-Malaysia-Selangor-Petaling Jaya
Organization JNTL Consumer Health (Malaysia) SDN. BHD.



Job Function Quality Assurance