Quality & Compliance Specialist

Quality & Compliance Specialist

What we do

At 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 NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent.

Who We Are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated.  We are 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 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.

Role reports to:

Quality System & Compliance Lead

Location:

Asia Pacific, Malaysia, Selangor, Petaling Jaya

Work Location:

Fully Onsite

What you will do

Summary

·    Individual with Growth mindset that is proactive and detail oriented. He/She will 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

·    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.

·    Responsible for overall batch record management compliance, product release and disposition on compliant and timely manner.

·    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.

·    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

·    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

·    To support in Quality Management Reviews, compliance forums, regulatory affair related activities as applicable

·    Maintain training program to all site personnel as well as assure alignment and enable knowledge / best practice

·    Maintain indirect supplier management program as per written procedures and cGMP requirements

·    Ensure documents and records are complete, accurate and documented/archived according to written procedures and cGMP requirements

·    To administer Quality System Electronic Platforms and support in their training and troubleshooting.

·    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.

·    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.

·    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.

 

Required Qualifications

·    Bachelor’s degree holder in Science or equivalent field

·    At least 3 years working experience in cosmetic / pharmaceutical / medical device / nutrition manufacturing environment or equivalent highly regulated cGMP industry

·    Growth mindset, proactive and detail oriented. Able to think strategically when dealing with challenges, solving problems, and multitask prioritization

·    Strive to constantly improve systems and practices in manufacturing site with respect to achieving compliance, reducing waste and improving efficiencies

·    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

·    Team player with excellent coordination, project management & organizing skills. Able to work independently and/or within team(s)

·    Able to work in a fast-paced environment, multi-task and undertake tasks on a timely & proactive manner with self-directed team concept

·    Ability to interpret related Quality Standards/Regulatory Guidelines & Requirements for implementation

·    Health Authority inspection and audit readiness preparation experience.

·    Experience in QMS applications, six sigma, lean principles, and process improvement tools are all added advantages

If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.