Quality Systems Manager

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.

Rollenberichte an:

Standort:

Arbeitsort:

Was Sie tun werden

A. Overall Responsibility:

• Governance process to ensure the compliance with quality system elements, GMP, ISO 9001 and Halal requirement.

• Lead quality audit program for both External and Internal audit.

• Ensure the compliance of audit action plan development and improvement

• Governance quality review and monitoring eg. Management review

• Ensure the achievement of Quality KPI

• Lead standards deployment and quality system initiatives

• Ensure the implementation of WW Procedure/Global SOP, QSP (Regional SOP), cGMP standard, Quality and Compliance as well as regional initiatives/procedures.

• Leading Quality System process eg. Document/record control, change control, complaint management, Non-conformance and CAPA, training via quality application: Tru, Compliance Wire, PQMS, and Symphony to ensure the compliance of data integrity, timeliness and effectiveness.

• Lead for manage complaint management for investigation, including monitoring complaint trend by provide complaint analysis report.

• Governance indirect material supplier management program.

• Ensure the implementation of Halal requirement ▪ Governance Pest control program

B. Principal Responsibilities:

• Lead and support for internal and external audit included of closing the findings are not according to standard.

• Develop internal audit plan and conduct auditor qualification, schedule the internal audit and develop internal audit report, including ensure the action is initiated for each audit observation. Ensure the effectiveness of action plan.

• Lead quality review and responsible for monthly report and management review preparation.

• Ensure completion of quality KPI record via Metric pulse.

• Deploy the quality standard and requirement for implementation at local level Deploy quality application: Tru, Compliance Wire, PQMS, and Symphony by provide training to all users and ensure that the users can use all application to record quality information.

• Conduct Gap analysis, training of standards, and deployment of new/updated WW Procedure/Global SOP, QSP (Regional SOP) to related functions.

• Manage complaint via PQMS system for part of investigation ensure action plan initiation, including effectiveness of the action with timely manner.

• Ensure the indirect supplier qualification process implement for new supplier and conduct the indirect supplier audit and internal assessment as per plan.

• Lead Halal activities eg. Halal internal audit, Halal management review, Halal supporting document review for New/alternative materials and ensure the compliance Halal requirement through the process.

• Plan and conduct the training courses per GxP requirement and local regulatory requirement.

• Responsible for quality system improvement in manufacturing process included WH, Production and all support function.

• Ensure pest control program in place and the procedure of pest control is follow and effective. Lead investigation to solve pest related issue

Key Result Areas:

• Zero Quality hold, Zero field action

• On-time for management review report and conduct the review as per procedure

• Compliance to Quality Policy, Enterprise standards, WW Procedures and Guidelines, Regional QSPs and local SOPs

• Internal Audit has been conducted as annual plan

• On-time for Audit Action Plan for both internal and external audit

• No critical observation from external audit

• 100% on time for complaint investigation closure

Key Qualifications:

Education:

• Bachelors degree in Science

Professional Experience:

• Experience in QA and QS field

• Extensive on quality auditing experience in a consumer product and medical device

• QA exposure to quality standard eg. ISO, GMP will be desirable.

• Knowledge/Understanding of GMP, ISO9001 or equivalent Quality Systems or Standards

Knowledge & Skills:

• Good knowledge of GMP and/or equivalent Quality Assurance Systems (eg. ISO 9001:2015)

• Having Quality Auditing skill

• Strong knowledge of GMPs, WWSPs, QSPs and other Quality Systems and Guidelines

• Strong communication skill with leadership abilities. Good coordination and interpersonal skills

• Good command of written and spoken English together with computer literacy

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