Job Description

DescriptionKenvue is currently recruiting for:Quality & Compliance SpecialistThis position reports into Quality System & Compliance Lead and is based at Petaling Jaya, Selangor Malaysia.Who We AreAt Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we're the house of iconic brands - including NEUTROGENAxc2xae, AVEENOxc2xae, TYLENOLxc2xae, LISTERINExc2xae, JOHNSON'Sxc2xae and BAND-AIDxc2xae Brand Adhesive Bandages that you already know and love. Science is our passion; care is our talent. Our global team is made up of ~ 22,000 diverse and brilliant people, passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact the life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage - and have brilliant opportunities waiting for you! Join us in shaping our future-and yours. For more information, click here .What You Will DoThe position is responsible for:

• Be part of Q&C team responsible for manufacturing site's Quality & Compliance and all aspects of quality assurance of raw & packaging materials, in process and finished products. This includes management of batch record, product release & disposition, change control, non-conformances (NC) & corrective and preventive actions (CAPA), complaint, validation master plan, documentation and records, supplier quality, GMP training program, internal audit (self-inspection) and regulatory inspections.

Key Responsibilities

• xe2x80xa2 Responsible for all aspects of quality assurance activities of raw and packaging materials, in process and finished products. And to provide oversight and collaborate cross functionally in ensuring site activities, projects, program and initiatives are executed and conforming to established specifications, procedures and in compliance of cGMP and Kenvue requirements.
• xe2x80xa2 Responsible for overall batch record management compliance, product release and disposition on compliant and timely manner.
• xe2x80xa2 Responsible for completeness of documentation prior to release of finished products under New Product Development (NPD), cost / quality compliance project with complete Authorization for Product Release (APR) / Global Change Control (GCC) and meeting quality requirement.
• xe2x80xa2 Ensure Validation activities such as Equipment & Facilities Qualification, Process Validation, Computer System Validation, etc. of the site are planned and carried out in accordance to Validation Master Plan and Kenvue requirement
• xe2x80xa2 Performs review, trending, tracking and monitoring of cGMP processes, procedures, training, documents and records, including but not limited to non-conformance records, change control, and corrective actions / preventive actions (CAPA), complaints investigation through respective electronic platform systems
• xe2x80xa2 To support in Quality Management Reviews, compliance forums, regulatory affair related activities as applicable
• xe2x80xa2 Maintain training program to all site personnel as well as assure alignment and enable knowledge / best practice
• xe2x80xa2 Maintain indirect supplier management program as per written procedures and cGMP requirements
• xe2x80xa2 Ensure documents and records are complete, accurate and documented/archived according to written procedures and cGMP requirements
• xe2x80xa2 To administer Quality System Electronic Platforms and support in their training and troubleshooting.
• xe2x80xa2 To Supports internal/external audits and inspections as part of audit/inspection management team. Plan, prepare and facilitate regulatory inspections on site including post-inspection follow-ups.
• xe2x80xa2 To support Shop Floor Quality Gemba in promoting proactive quality culture and ensuring the Quality and Compliance of shop floor as per company standards and requirements.
• xe2x80xa2 Actively join and/or support cross-functional project(s), continual improvement and LEAN initiatives, regulatory-related applications / submissions / cascades, and global and regional strategic initiatives to drive compliance and process improvement and robustness as assigned by manager.

What We Are Looking ForRequired Qualifications

• xe2x80xa2 Bachelor's degree holder in Science or equivalent field
• xe2x80xa2 At least 3 years working experience in cosmetic / pharmaceutical / medical device / nutrition manufacturing environment or equivalent highly regulated cGMP industry
• xe2x80xa2 Health Authority inspection and audit readiness preparation experience.
• xe2x80xa2 Ability to interpret related Quality Standards/Regulatory Guidelines & Requirements for implementation
• xe2x80xa2 Experience in QMS applications, six sigma, lean principles, and process improvement tools are all added advantages
• xe2x80xa2 Growth mindset, able to think strategically when dealing with challenges, solving problems, and multitask prioritization
• xe2x80xa2 Strive to constantly improve systems and practices in manufacturing site with respect to achieving compliance, reducing waste and improving efficiencies
• xe2x80xa2 Proficient in both written and verbal presentation and communication skills. Able to communicate openly and with clarity while interacting with people at various levels of the organization
• xe2x80xa2 Team player with excellent coordination, project management & organizing skills. Able to work independently and/or within team(s)
• xe2x80xa2 Able to work in a fast-paced environment, multi-task and undertake tasks on a timely & proactive manner with self-directed team concept

What's In It For You

• xe2x80xa2 Competitive Benefit Package
• xe2x80xa2 Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!
• xe2x80xa2 Learning & Development Opportunities
• xe2x80xa2 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.

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