Total 2,293 senior manager job vacancies in Quality Assurance / Control category in Malaysia

Responsibilities:

• Determine quality improvement parameters.
• Identify statistical methods relevant to manufacturing processes.
• Identify sample size and acceptable error.
• Establish statistical reliability and perform reliability demonstration tests.
• Analyze data by completing hypothesis, normal distribution, and process capability analysis tests.
• Prepare reports by collecting, analyzing, and make recommendations.

 

Requirements:

• Excellent numerical skills and understanding of data analysis/statistical methods.
• Good knowledge of MS Office and databases.
• Exceptional communication skills.
• Good attention to detail and a results driven approach.
• Reliable and Trustworthy.
• Possess at least a Bachelor's Degree in Business Administration or relevant field.
• Certification of quality control is a strong advantage (ISO 9000 etc.).

Perks & Benefits

• Commission and bonus
• Allowance (travel stipends, transportation, etc.)
• Work visa sponsorship
• Personal development opportunities
• Annual Leave up to 21 day per year

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

職責：

• 確定品質改進參數。
• 確定與製造過程相關的統計方法。
• 確定樣本大小和可接受的誤差。
• 建立統計可靠性並進行可靠性論證測試。
• 透過完成假設、常態分佈和製程能力分析檢定來分析資料。
• 透過收集、分析和提出建議來準備報告。

要求：

• 出色的數字技能和對數據分析/統計方法的理解。
• 熟悉 MS Office 和資料庫。
• 優秀的溝通技巧。
• 注重細節和以結果為導向的方法。
• 可靠且值得信賴。
• 至少擁有工商管理或相關領域的學士學位。
• 品質控制認證是一個強大的優勢（ISO 9000 等）。

津貼和福利

• 佣金和獎金
• 津貼（旅費、交通費等）
• 工作簽證贊助
• 個人發展機會
• 年假最多 21 天

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

Mandatory

• Experience utilizing open-source automated testing frameworks such as Selenium, Cucumber, and JUnit, or enterprise-level testing tools.
• Proficiency in employing open-source performance testing tools.
• Experience in leveraging open-source penetration testing tools.

Responsibilities include but are not limited to:

• Develop and maintain comprehensive test cases and plans, ensuring alignment with requirements and policy updates.
• Enhance and manage the automated test framework and testing environments to ensure efficiency and reliability.
• Execute tests on new functionalities, promptly identifying and documenting any issues encountered.
• Perform a diverse range of tests including manual, functional, performance, and exploratory tests, while supporting User Acceptance Testing (UAT).
• Collaborate in resolving production issues as they arise.

Why join us?

You will have opportunities to hone your functional skills and expertise in an area of specialization. We offer a variety of formal and informal training programs at every level to help you acquire and build specialized skills faster. Learning takes place both on the job and through formal training conducted online, in the classroom, or collaboration with teammates. The sheer variety of work we do, and the experience it offers, provide an unbeatable platform from which to build a career.

Accenture is an equal opportunities employer and welcomes applications from all sections of society and does not discriminate on grounds of race, religion or belief, ethnic or national origin, disability, age, citizenship, marital, domestic or civil partnership status, sexual orientation, gender identity, or any other basis as protected by applicable law.

The Organization

Accenture is an Irish-domiciled multinational professional services company that provides services in:

1) Technology

2) Strategy & Consulting

3) Song

4) Operations

As a Fortune Global 500 company, it has been incorporated in Dublin, Ireland since September 1, 2009.

With more than 700,000 employees worldwide—in 200 cities across 51 countries—Accenture also operates more than 100 “innovation hubs,” developing solutions for cloud, finance, and other industries.

The Pillar

Accenture Technology combines business and industry insights with innovative technology services to transform your business. Join one of the world’s largest independent providers of technology services to grow your expertise and help clients worldwide to innovate at scale and transform their businesses. Help change how the world works and lives

through technology innovation.

The Group(s)

Accenture Health & Public Services Consulting (HPS) balances the stability of service delivery with the speed to react to citizens’ changing needs. By maximizing the value of existing investments and expertise, we help build the foundations of material improvement that delivers sustainable value for citizens and creates lasting capability within government.

The result is more agile government, with services that respond to individual needs, empowered civil service teams that are ready for anything and an efficient technology infrastructure that can scale rapidly.

Accenture Cloud First / Cloud Infrastructure & Engineering (CIE) is a new multi-service group of 70,000 cloud professionals that brings together the full power and breadth of Accenture’s industry and technology capabilities, ecosystem partnerships, and deep commitment to learning and upskilling clients’ employees and to responsible business, with the singular focus of enabling organizations to move to the cloud with greater speed and achieve greater value for all their stakeholders at this critical time. Specifically, this new group integrates the company’s wide-ranging cloud expertise, including:

· Software Development, Cloud migration, infrastructure, and application services and ecosystem partnerships; deep industry and cross-industry insights, data, and Applied Intelligence capabilities.

• Prepare quality reports, perform process audit, develop & implements quality assurance standards, policies, processes & controls.
• Able to Liaise & resolve with customers on quality related issues.
• Data Compilation, Co-ordination and facilitation of all internal and external audits, re-certification of ISO 9001.

• Prepare quality reports, perform process audit, develop & implements quality assurance standards, policies, processes & controls.
• Able to Liaise & resolve with customers on quality related issues.
• Data Compilation, Co-ordination and facilitation of all internal and external audits, re-certification of ISO 9001.

Summary

The Senior Manager, Quality Assurance is responsible for overseeing the Singapore site’s QMS as Site Quality Leader and Quality Management Representative. The position will provide guidance and support to the Singapore site’s quality team and will work closely with the Director of Quality, VP of Operations, and APAC regional business partners.

Key Accountabilities

• Appointed as the Singapore Quality Management Representative and Singapore Quality Site Leader for ISO 9001:2015 QMS.
• Ensure effectiveness and compliance to ISO 9001:2015 and various regulatory requirements as needed.
• Lead site quality team to drive operation and product quality improvements via data driven metrics.
• Oversee and support supplier quality, SCAR, product inspection, equipment calibration, CAPA, complaint investigation, change control, LMS training, and NPI activities.
• Chair quality management reviews and manage Internal & External audits.
• Support global quality system process integration, harmonization, and simplification. Managing local implementation and changes.
• Manage employee recruitment and development, performance management, and motivate team to achieve departmental objectives and goals.
• Escalate and manage any significant events such as safety, product shipping holds due to quality, regulatory, or any compliance issue.
• Lead or support identified special projects and key initiatives as needed.
• Work cross-functionally to achieve Singapore site objectives.

Requirements

• 8+ years of experience in Quality Management Systems within the medical device or pharmaceutical industry or under an ISO 13485:2016 or ISO 9001:2015 QMS.
• 5+ years of management experience.
• Knowledge of regulatory requirements and standards relevant to manufacturing such as (ISO45001/OHSAS18001 and ISO14001)
• Strong customer focus with complaint investigation, significant event reporting and CAPA skills.
• Internal Auditor certification.
• Strong data analysis skills and proficiency in electronic data management systems.
• Good understanding of quality management systems and tools such as PPAP, FMEA, and SPC.
• Ability to work independently and collaborate effectively with cross-functional teams.
• Proficiency in SAP, Microsoft Excel, Word, and PowerPoint.

Responsibilities:

We are looking for compliance personnel to assist in enhancing the compliance risk framework of the company. The candidate will help to manage and execute the compliance programs, provide policy guidance and to carry out compliance training for the company’s diversified investment business groups. Depending on the candidate’s experience, duties will include the following:

• Conduct compliance reviews and monitoring/surveillance across the company’s business activities;

• Develop risk-based compliance programs to facilitate the execution of compliance reviews and monitoring;

• Advise the business units in meeting regulatory requirements through implementing appropriate compliance risk policies, assisting with the design and implementation of risk and compliance management initiatives, and enhancing and improving internal processes and procedures;

• Review the completed risk and compliance assessment returns from each area of the business, identifying trends and areas of concern and working with the business units to reduce any unacceptable exposures to regulatory risk;

• Provide compliance training and support through issuing of internal compliance updates, training modules and compliance guidelines

Requirements:

• Minimum 3-5 years’ relevant experience in compliance, audit or risk management in the securities, financial advisory or fund management industry

• Should have knowledge of key applicable regulations in Singapore such as the Securities & Futures Act, Financial Advisers Act, MAS Notices and Guidelines, AML/CFT regulations

• Excellent writing and communication skills

• Good interpersonal, influencing and networking skills

• Team player

Responsibilities:

We are looking for compliance personnel to assist in enhancing the compliance risk framework of the company. The candidate will help to manage and execute the compliance programs, provide policy guidance and to carry out compliance training for the company’s diversified investment business groups. Depending on the candidate’s experience, duties will include the following:

• Conduct compliance reviews and monitoring/surveillance across the company’s business activities;

• Develop risk-based compliance programs to facilitate the execution of compliance reviews and monitoring;

• Advise the business units in meeting regulatory requirements through implementing appropriate compliance risk policies, assisting with the design and implementation of risk and compliance management initiatives, and enhancing and improving internal processes and procedures;

• Review the completed risk and compliance assessment returns from each area of the business, identifying trends and areas of concern and working with the business units to reduce any unacceptable exposures to regulatory risk;

• Provide compliance training and support through issuing of internal compliance updates, training modules and compliance guidelines

Requirements:

• Minimum 3-5 years’ relevant experience in compliance, audit or risk management in the securities, financial advisory or fund management industry

• Should have knowledge of key applicable regulations in Singapore such as the Securities & Futures Act, Financial Advisers Act, MAS Notices and Guidelines, AML/CFT regulations

• Excellent writing and communication skills

• Good interpersonal, influencing and networking skills

• Team player

Key Responsibilities

• Ensure completionof key orders and troubleshoot any issues
• Coordinate QC and QA work within the team
• Perform statistics and analysis of production data, assisting the supervisor in optimizing and improving production processes or technology
• Participate in or manage multiple internal and external projects, ensuring the achievement of project objectives
• Draft and update SOPs, summarize and consolidate work experience, and train junior employees
• Assist the supervisor in quality monitoring and safety inspections, promptly addressing any problems
• Complete other tasks assigned by the supervisor

Key Requirements

• Bachelor’s degree or above in cell biology, molecular biology, biomedicine, or related fields
• Proficiency in experimental operations such as SDS-PAGE, Western blot, ELISA, SPR, BLI, HPLC, and other protein detection methods, with over 3 years of laboratory experience
• Expertise in protein mass spectrometry analysis techniques, including instrument operation and data analysis, familiarity with mass spectrometry analysis software, and capabilities in experimental design and operation
• Strong troubleshooting and project management skills
• Excellent verbal and written communication skills
• Ability to work effectively in a team environment

Be a Part of Something BIG!

The Test Engineer will focus on improving internal testing processes, leadership, and organisation of testing teams across Group network, and be hands-on with both manual and automation software testing. The test Engineer will support several key web/mobile product initiatives through the full agile software development lifecycle.

The key technical skills are based around Web and Mobile testing so experience in a similar environment is essential and any experience with Performance and/or Load testing is highly desirable.

You’ll be assisting developers and other testers in automating complex testing scenarios utilising your skills and experience whilst also supporting the existing manual testing effort, suggesting appropriate tools that would best fit the solution, and identifying opportunities to automate and improve the company’s software quality.

The Test Engineer will optimise and automate currently manual backend processes, so experience in business process engineering and optimisation would be advantageous.

Make an Impact by

• Design & implement tests for Web/Mobile applications
• Ensure acceptance tests meet acceptance criteria for your squad
• Support release with automation first mindset
• Raising issues & impediments as early as possible
• Foster partnership with upstream and downstream teams

Skills for Success

• Bachelor’s Degree in Computer Science
• Has minimally 7 years of working experience as a Test Engineer
• Has knowledge in Web/UI/Mobile testing, JSON, XML, JIRA/Confluence, SQL, Hands-on development and testing process
• Strong onflict Resolution skills
• Has strong analytical skills
• Strong Communication and team player skills

Your Career Growth Starts Here. Apply Now!

We are committed to a safe and healthy environment for our employees & customers and will require all prospective employees to be fully vaccinated.

22nd April, 2024
Were a globally integrated audit, tax and advisory firm present in over 100 countries and territories and were always ready to recruit an experienced and motivated new Senior Assurance Analyst like you to join our Australian team.   This could be just the right opportunity for you if you

Love to travel between home, office and client venues and enjoy the variety that comes with working in different environments.
Like to work collaboratively with clients and colleagues and find communication and people management easy.
Are keen to progress to increasing levels of seniority and receive training and promotions you deserve.
Believe that a great culture is built on the celebration of collective success.

About the role
As an experienced member of our Audit team, your job will involve:


Planning performed in accordance with the

... Click here to view more detail / apply for Senior Assurance Analyst

APS Level 6
Canberra ACT,Penrith NSW,Darwin NT,Brisbane QLD,Adelaide SA,Hobart TAS,Melbourne, VIC,Perth WA,Parramatta NSW


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You have begun to prove your worth in our industry! How has the experience been so far? We hope it has been rewarding. At Nagarro, we want to take the word “hope” out of that sentence. At Nagarro, if you are ready to take the next step, we are ready to take you to the next level. Want to work with the coolest tech, the brightest minds, and be able to solve the most challenging problems, then look no further.