Job Description

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-including NEUTROGENA\xc2\xae, AVEENO\xc2\xae, TYLENOL\xc2\xae, LISTERINE\xc2\xae, JOHNSON\'S\xc2\xae and BAND-AID\xc2\xae -are 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\' hearts and homes.

What will you do

The Quality System Specialist is responsible for maintenance of site Quality & Compliance Systems, such as change control management, non-conformances, corrective and preventive actions, documentation and records management, indirect supplier management, GMP training program, internal audit (self-inspection) and regulatory inspections.

Key Responsibilities

• Maintain and review QMS policies or procedures
• Collaborates cross functionally as needed to ensure the QMS processes are executed in accordance with established procedures
• 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) through respective electronic platform systems
• Train site personnel on such systems and act as a key user / system administrator for such systems on site
• 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
• 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. Establish internal audit plans and execute such plans and follow-ups to meet regulatory requirements.
• Actively join and/or support cross-functional project(s), continual improvement and LEAN initiatives, regulatory-related applications / submissions / cascades, and company-wide initiatives as assigned by manager

Qualifications

What we are looking for

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
• Experiences and knowledge in following areas are required:
• cGMP relevant QMS, with experience from regulated industry having added advantage
• Health Authority inspection and audit readiness including Halal QMS
• Maintain current knowledge of local and applicable internal regulatory and legislative requirements and trends with respect to Quality & Compliance systems. Ability to interpret related Quality Standards/Regulatory Guidelines & Requirements for implementation and review
• Strive to constantly improve systems and practices on site with respect to achieving compliance, reducing waste and improving efficiencies
• Experience in operations applications, six sigma, lean principles, and process improvement tools are all added advantages
• Growth mindset, able to think strategically when dealing with challenges, solving problems, and multitask prioritization
• 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

What\'s 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.

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