Executive - Compliance

3 weeks ago

Penang, Malaysia B. Braun Medical Ind. Sdn. Bhd. Full time

**Duties and responsibilities**:

- To be responsible and accountable for all aspects regarding compliance, complaints and CAPS, to ensure proper and smooth operations of the plant.
- To evaluate and monitor on plant's procedure /SOP/documentation/specification/records and to ensure they are in compliance with daily practice/operation of the assigned plant.
- To propose and to implement Corrective Action needed to align the compliance of plant practice and documentation.
- To ensure GMP compliance to regulatory requirements such as FDA/TUV.
- To coordinate necessary activites within the plant before, during and after the audits, internal and external.
- To coordinate all corrective actions needed after audits and to ensure timely response and implementation of corrective actions.
- To coordinate all CAPAs activites within the department and to ensure that al CAPAs are closed timely.
- To coordinate and monitor market complaints and to ensure timely feedfack/closure.
- To propose and implement necessary corrective actions related to market complaints, conduct internal audits within own division from time to time and to monitor/update on CAPA/market complaints during plant's regular meetings.
- The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.

**Professional competencies**:

- Bachelor Degree in Engineering / Science or equivalent
- 1-2 years working experiences in quality /compliance /regulatory affair.
- Knowledge of Quality Management Systems related to Medical Devices, eg.: ISO13485, MDSAP, 21 CFR Part 820, GMP.
- Knowledge of Corrective Action and Preventive Action (CAPA) processes and Root Cause Analysis (RCA).
- Quality auditing experience or exposure to quality audit environment.
- Plan and execute necessary activities within the plant before, during and after the audits, internal and external.
- Evaluate and monitor on plant's procedure /SOP/documentation/specification/records and to ensure they are in compliance with daily practice/operation.
- Preferably in experience in driving continuous improvement in Quality / Compliance project with strong communication, coordination and follow-up skills.
- Preferably good statistical analysis skills and familiarity with tools (Pie chart, Histogram, Power BI etc)

**Personal competencies**:

- Be accountable.
- Communicate effectively.
- Execute efficiently.

**What we offer**:
Become part of a corporate culture that actively promotes constructive exchanges between colleagues, customers and partners. Work with us to improve people's lives in the long term. We can offer you interesting, varied tasks and excellent opportunities for advancement, as well as an attractive salary with extensive benefits, all within a dynamic family-owned company.

**Closing date**:

- 2024-05-31

  • Ethics and Compliance Staff Specialist

    4 days ago

    Penang Island, Malaysia Advanced Micro Devices, Inc. Full time

    Back **Ethics and Compliance Staff Specialist**: - Penang, Malaysia - General Management/ Administration/ Support - 39120 mail_outline Get future jobs matching this search *** **Job Description**: **WHAT YOU DO AT AMD CHANGES EVERYTHING** - We care deeply about transforming lives with AMD technology to enrich our industry, our communities, and the world....

  • Global Trade Compliance Manager

    4 days ago

    Penang Island, Malaysia Advanced Micro Devices, Inc. Full time

    Back **Global Trade Compliance Manager**: - Penang, Malaysia - General Management/ Administration/ Support - 38658 mail_outline Get future jobs matching this search *** **Job Description**: **WHAT YOU DO AT AMD CHANGES EVERYTHING** - We care deeply about transforming lives with AMD technology to enrich our industry, our communities, and the world. Our...

  • Executive, Personal Financial Services

    1 day ago

    Penang, Malaysia Hong Leong Bank Full time

    If you are looking to excel and make a difference, take a closer look at us We are currently looking for talents to: - Meeting allocated funding target - Identify and recruit potential new dealers from area under your care - Develop and manage the relationship of car dealers assigned to you - Ensure documentation on all new loans sourced are complete -...

  • HR Admin Executive

    3 days ago

    Penang, Malaysia Zhongshi Chemical Engineering Construction ( Malaysia ) Sdn Bhd Full time

    **Key Roles & Responsibilities: - ** Human Resources: - Assist in recruitment processes, including job posting, resume screening, and interview coordination. - Handle onboarding and orientation for new employees. - Maintain employee records, including personal information, attendance, and leave records. - Assist with HR-related documentation and...

  • Intern - Finance

    3 days ago

    Penang, Malaysia Advanced Energy Industries, Inc Full time

    **Responsibilities** - To perform Bank reconciliation. - To perform AR sales sales invoices and SOA. - To verify employees concur claim and compliance. - Maintain sound documentation system to support accurate reporting. - To perform expenses analysis. - To work with users on the fixed assets series number and update into SAP. - Collect DMR Scrap form and...

  • Equipment Engineer

    Found in: beBee S MY - 4 weeks ago

    Penang, Malaysia PERSOLKELLY Malaysia Full time

    Location : Batu Kawan, Penang Objectives: To ensure the equipment is manufactured according to specifications, and meets all performance and safety standards through FAT (Factory Acceptance Test (FAT), Installation Verification and Operational Testing, Software validation and Process validation. To install and set up the equipment in accordance with...

  • Finance Executive

    1 day ago

    Penang, Malaysia Ambu Full time

    Business Area: Finance- Employment type: Full-time**Responsibilities**: - Responsible for accurate and timely daily accounting operations, handling full set of accounts includes GL, AP, AR and Treasury, month end closing, cash flow forecast and VAT reconciliation. - Support preparation of yearly budget & quarterly forecast. - Support other entities in APAC...

  • Customer Service Executive

    5 days ago

    Penang, Malaysia Bright Prospect Full time

    Full Time _Penang_ April 30, 2024 Customer Service & Operations **Job Overview**: - **Salary **RM3,500-RM5,000 **Location**: Perai, Penang Multilevel Marketing company Products: Water Filter, Air Purifier, Supplement **Job Descriptions**: - Resolve customer complaints. - Develop policies and procedures and oversee the customer service processes. -...

  • Document Controller Executive

    4 days ago

    Penang, Malaysia JAC Malaysia Full time

    Location: - Penang- Specialisation: - Engineering & Manufacturing- Salary: - MYR 48,000 - 54,000 (Annual)- Reference: - PR/156904- Contact details: - Kee Eng Chew- Job published: - March 06, 2024 11:54**JOB DESCRIPTIONS** - Possess wide knowledge on ISO9001 - To manage and handle documented information related to the Document Control. - Assist the Quality...

  • Quality Analyst 1

    4 days ago

    Penang, Malaysia Dexcom Full time

    About Dexcom Founded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming diabetes care and management by providing CGM technology to help patients and...

  • Senior Facilities Manager

    Found in: beBee S MY - 3 weeks ago

    Penang, Malaysia Randstad Malaysia Full time

    about the companyYour future employer is a reputable real estate services and investment firm, specialising in managing industrial projects. The team is expanding extensively and looking for the right talents who can add value to the company's business.about the jobLead the implementation of operation-related standards and procedures, preventive & planned...

  • Senior Facilities Manager

    Found in: beBee S MY - 3 weeks ago

    Penang, Malaysia Randstad Malaysia Full time

    about the companyYour future employer is a reputable real estate services and investment firm, specialising in managing industrial projects. The team is expanding extensively and looking for the right talents who can add value to the company's business.about the jobLead the implementation of operation-related standards and procedures, preventive & planned...

  • AP Accountant

    Found in: beBee S MY - 4 weeks ago

    Penang, Malaysia PERSOLKELLY Malaysia Full time

    AP Accountant  -looking for a detail-oriented & skilled AP Accountant to join the newly set up finance SSC. - Prefer MNC or shared service experience Responsibilities Process invoices timely and accurately. Follow up with vendors and the internal team to resolve discrepancies in a timely manner. Respond...

  • Manager - Digital Communications, Asia Pacific

    4 days ago

    Penang, Malaysia B. Braun Medical Ind. Sdn. Bhd. Full time

    **Duties and responsibilities**: - Regional responsibility for the implementation of technical solutions for digital communications, which include corporate websites, the company intranet, the central product information management system, social media sites and the media asset database. - Close coordination with respective global process owners to...

  • Complex Assistant Purchasing Manager

    4 days ago

    Penang, Malaysia Marriott International, Inc Full time

    **Job Number** 23115583 **Job Category** Finance & Accounting **Location** Penang Marriott Hotel, One Marriott Drive, Penang, Malaysia, Malaysia **Schedule** Full-Time **Located Remotely?** N **Relocation?** N **Position Type** Management **HOTEL DESCRIPTION** Perfectly positioned along Gurney Drive, a popular seafront promenade in George Town,...

  • Internal Audit Analyst

    20 hours ago

    Penang Island, Malaysia S&P Global Full time

    S&P Global Corporate **Role**: Internal Audit Analyst **Grade (relevant for internal applicants only)**: 8 or 9 **The Location**: Penang or Kuala Lumpur, Malaysia **The Team**: S&P Global (SPGI) is a leader in credit ratings, benchmarks and analytics for the global capital and commodity markets. This is a key role in supporting the execution of SOX...

  • Manufacturing Associate 4

    3 days ago

    Penang, Malaysia Dexcom Full time

    About Dexcom Founded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming diabetes care and management by providing CGM technology to help patients and...

  • Direct Sales Manager

    7 days ago

    Penang, Malaysia Astro Full time

    WHY JOIN US?- We practice a vibrant & energetic office culture.- We provide opportunities for career advancement within the company.- Good performance is always rewarded accordingly. “_It's our people that make Astro Malaysia’s leading entertainment company. We are an inclusive employer, to enable everyone at Astro to be their best. We embrace...

  • Lead Premedia Artist

    4 days ago

    Penang, Malaysia SGK Full time

    **SGK is a global packaging and brand experience company. From idea to implementation, we deliver packaging solutions and brand experiences that give brands the freedom to speak louder, scale faster and grow stronger. We simplify marketing and amplify brands to deliver value. SGK is a Matthews International company.** **Position Summary**: Working within...

  • IT Asset Manager

    4 days ago

    Penang Island, Malaysia Advanced Micro Devices, Inc. Full time

    Back **IT Asset Manager**: - Penang, Malaysia - Information Technology - 39320 mail_outline Get future jobs matching this search *** **Job Description**: **WHAT YOU DO AT AMD CHANGES EVERYTHING** - We care deeply about transforming lives with AMD technology to enrich our industry, our communities, and the world. Our mission is to build great products...