Total 4 Product Safety Manager inKuala Lumpur job vacancies in Quality Assurance / Control category in The United States of America

Job Responsibilities

• Conduct comprehensive market research and analysis to identify customer needs, market trends, and competitor strategies.
• Collaborate with cross-functional teams to guide product development, from concept to launch, ensuring alignment with customer needs and business goals.
• Develop and implement go-to-market strategies and product positioning to maximize product potential.
• Monitor product performance metrics, analyze sales data, and generate reports on market trends and competitive analysis.
• Manage the entire product ordering process, including demand forecasting, inventory control, and supplier negotiations.
• Oversee purchase order management, ensuring accuracy, compliance, and timely processing of orders.
• Establish and maintain strong relationships with suppliers, negotiating contracts and terms to secure the best conditions and ensure supply stability.
• Implement and maintain inventory and quality control processes to manage stock levels, ensure product quality, and comply with industry standards.
• Coordinate logistics and distribution strategies, optimizing product availability and minimizing costs.
• Regularly review procurement and supply chain processes for cost reduction and process improvement opportunities.
• Serve as a liaison between customers, suppliers, and internal teams to resolve any product-related issues.
• Prepare and present regular reports to senior management on product performance, inventory status, and supply chain efficiency.

Perks & Benefits

• Commission and bonus
• Free snacks / Happy hours
• Regular team activities
• Medical insurance
• Personal development opportunities

Job Responsibilities:

1. New product registration:

• Prepare and compile registration dossiers in accordance with relevant regulatory requirements including: 
  

  • Constructing/ editing letters of response/ justification/ declaration and clinical documentation for submission packages in accordance with guidelines checklists.

  • Compile/ review/check material for dossier prior to submission, incorporate feedback from relevant stakeholders.

  • Conduct checks on artworks to ensure in compliance with local regulation.

• Submit product registration applications to local health authorities  according to target submission timelines.
• Liase with and respond to additional requests or queries from health authorities and follow up (when necessary) until approval per target timelines.
• Liase with enternal and external stakeholders/ departments to build rapport and to achieve target outcomes.

2. Comply with regulatory requirements: to maintain validity of existing licenses/ certification/ authorization (e.g, product licenses, manufacturing licenses, establishment license, GDPMD licenses, import/ export license) through timely variations and/ or renewals to ensure supply continuity.

3. Keep abreast of regulatory updates from health authorities in the drugs, cosmetics, and medical device space.

• Assess regulatory updates on impact to business and communicate insights on approach to handle affairs.
• Propose solutions to arising issues.

4. Update and maintain database of regulatory and product registration information.

5. Good maintenance of final submitted documentation and local repository.

6. Ensure compliance with quality procedures stipulated for regulatory affairs, its administartive maintenance, and plan/ suggest improvements to operations.

7. Support any audits or inspections.

8. Guide/ oversee work performance and development of direct report.

9. Provide input for periodic operation metrics/ budget initiatives by managing  operating expenses within approved budget for the year.

10. Handle any other assingment as advised by supervisor.

Requirements: 

• Possess a Bachelor Science
• Work experience in regulatory affairs.
• Familiar with drugs/ cosmetics/ medical device regulatory landscape and GxP related matters.
• Proficiency in Microsoft Office Applications and relevant regulatory system software.
• Adopt good practices in documentation and communication.

Perks & Benefits

• Allowance ( mileage,transportation)
• Medical insurance

The incumbent must ensure the quality, safety, and compliance of products throughout the processing and production stages. Besides, the incumbent needs to pay attention to detail when inspecting products, conducting tests, and recording data accurately.

Job Responsibilities:

·         To inspect bird condition before and after process (ante mortem & postmortem)

·         Check and record stunner, bleeding time, scalder temperature for every process.

·         To ensure all processes follow the standard operation procedure.

·         Check, record and maintain spinechiller and chicken temperature during process.

·         Check and record the lorry’s temperature and condition before the loading process.

·         To ensure all product in good quality before delivering to customers.

·         Receive and check any incoming material.

·         To participate and assist during audit from authorities or customer.

·         To report any finding of non-compliance to management team.

·         Perform any other duties assigned by superior/management from time to time.

Job Requirements:

·         A Bachelor's Degree in a relevant field such as Food Science, or a related discipline is preferred.

·         Familiarity with ISO standards, GMP, HACCP and HALAL are added advantages.

·         Effective communication skills are essential to collaborate with other departments, report findings, and explain quality issues and solutions.

Perks & Benefits

• Medical insurance
• Open culture

工作職責：

1、新產品註冊：

• 根據相關監管要求準備和編制註冊檔案，包括：
  

  • 根據指南清單建立/編輯提交包的回應/理由/聲明和臨床文件。

  • 在提交之前編譯/審查/檢查檔案資料，納入相關利害關係人的回饋。

  • 對藝術品進行檢查，以確保符合當地法規。

• 根據目標提交時間表向當地衛生部門提交產品註冊申請。
• 與衛生當局聯絡並回應其他請求或詢問，並跟進（必要時）直至按照目標時間表獲得批准。
• 與內部和外部利害關係人/部門聯絡，建立融洽關係並實現目標成果。

2. 遵守監管要求：透過及時變更和/或更新來維持現有許可證/認證/授權（例如產品許可證、製造許可證、企業許可證、GDPMD許可證、進出口許可證）的有效性，以確保供應連續性。

3. 隨時了解衛生當局在藥品、化妝品和醫療器材領域的最新監管動態。

• 評估監管更新對業務的影響，並就處理事務的方法傳達見解。
• 針對出現的問題提出解決方案。

4.更新和維護監管和產品註冊資訊資料庫。

5. 妥善維護最終提交的文件和本機儲存庫。

6. 確保遵守監管事務、行政維護規定的品質程序，並規劃/建議營運改善。

7. 支持任何審計或檢查。

8. 指導/監督工作績效和直接報告的發展。

9. 透過在年度核准的預算內管理營運費用，為定期營運指標/預算計畫提供輸入。

10. 處理主管建議的任何其他分配。

要求：

• 擁有科學學士學位
• 監管事務方面的工作經驗。
• 熟悉藥品/化妝品/醫療器材監管環境和 GxP 相關事宜。
• 熟練Microsoft Office應用程式和相關監管系統軟體。
• 在文件和溝通方面採用良好的做法。

津貼和福利

• 津貼（里程、交通）
• 醫療保險