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Quality Systems Manager

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Quality Systems Manager

Wat we doen

Bij Kenvue realiseren we de buitengewone kracht van dagelijkse verzorging. Gebouwd op meer dan een eeuw erfgoed en geworteld in de wetenschap, zijn we het huis van iconische merken - waaronder NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® en BAND-AID® die je al kent en waar je van houdt. Wetenschap is onze passie; Zorg is ons talent.

Wie we zijn

Ons wereldwijde team bestaat uit ~ 22.000 briljante mensen met een werkcultuur waar elke stem telt en elke bijdrage wordt gewaardeerd. We zijn gepassioneerd door inzichten, innovatie en toegewijd aan het leveren van de beste producten aan onze klanten. Met expertise en empathie betekent een Kenvuer zijn dat je elke dag de kracht hebt om miljoenen mensen te beïnvloeden. We stellen mensen op de eerste plaats, geven er veel om, verdienen vertrouwen met de wetenschap en lossen op met moed - en hebben schitterende kansen voor je klaarliggen! Geef samen met ons vorm aan onze toekomst - en die van jou. Klik voor meer informatie op here.

Rol rapporteert aan:

Director, Quality & Compliance Thailand Make Quality

Locatie:

Asia Pacific, Thailand, Bangkok, Bangkok

Werklocatie:

Volledig ter plaatse

Wat je gaat doen

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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