Quality & Compliance Specialist

Was wir tun

Bei Kenvue erkennen wir die außergewöhnliche Kraft der täglichen Pflege. Aufbauend auf über einem Jahrhundert Tradition und verwurzelt in der Wissenschaft, sind wir das Haus der ikonischen Marken - darunter NEUTROGENA®, AVEENO®, TYLENOL,® LISTERINE®, JOHNSON'S® und BAND-AID®, die Sie bereits kennen und lieben. Wissenschaft ist unsere Leidenschaft; Fürsorge ist unser Talent.

Wer wir sind

Unser globales Team besteht aus ~ 22.000 brillanten Mitarbeitern mit einer Arbeitsplatzkultur, in der jede Stimme zählt und jeder Beitrag geschätzt wird. Wir sind leidenschaftlich an Erkenntnissen interessiert, Innovation und dem Engagement, unseren Kunden die besten Produkte zu liefern. Mit Fachwissen und Einfühlungsvermögen bedeutet ein Kenvuer zu sein, die Macht zu haben, jeden Tag Millionen von Menschen zu beeinflussen. Wir stellen den Menschen an die erste Stelle, kümmern uns leidenschaftlich, gewinnen Vertrauen in der Wissenschaft und lösen Lösungen mit Mut – und haben brillante Möglichkeiten, die auf Sie warten! Gestalten Sie mit uns unsere Zukunft – und Ihre. Für weitere Informationen, klicken Sie auf hier.

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Was Sie tun werden

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

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