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Quality Systems Manager

職位類別:
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結束日期:
ID:
2507035213W

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Kenvue 目前正在招聘 a:

Quality Systems Manager

我們做什麼

Kenvue,我們意識到日常護理的非凡力量。我們以一個多世紀的傳統為基礎,植根於科學,是標誌性品牌的品牌 - 包括您已經熟悉和喜愛的 NEUTRGENA®、AVEENO、TYLENOL®®、LISTERINE®、JOHNSON'S® 和 BAND-AID®。科學是我們的熱情所在;關心就是我們的才能。

我們是誰

我們的全球團隊由 ~ 22,000 名才華橫溢的員工組成,他們的職場文化中,每個聲音都很重要,每一個貢獻都受到讚賞。 我們熱衷於洞察, 創新並致力於為我們的客戶提供最好的產品。憑藉專業知識和同理心,成為 Kenvuer 意味著每天有能力影響數百萬人。我們以人為本,熱切關懷,以科學贏得信任,以勇氣解決——有絕佳的機會等著您!加入我們,塑造我們和您的未來。有關更多資訊,請按兩下 here.

Role reports to:

Director, Quality & Compliance Thailand Make Quality

位置:

Asia Pacific, Thailand, Bangkok, Bangkok

工作地點:

完全現場

你會做什麼

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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