Total 7 job vacancies by NRS Global Partners Sdn Bhd

Responsibility :

A. Documents Control

1) Assisting in managing quality document control system.

2) Preparing and revising Quality Procedures for process owner.

3) Preparing Document Change Notice.

4) Issuing document with identification of 'Master Copy', 'Controlled Copy', 'Uncontrolled Copy' and 'For

Training Purpose only'.

5) Updating and maintaining Document Master List and Records Master List and controlling the distribution

of documents within the Quality & Regulatory Compliance Management System (QRCMS).

6) Maintaining Master Copy, Controlled Copy and Obsolete documents.

B. Technical Documentation

1) Assisting in composing and maintaining Technical Documentation in accordance with EU MDR 2017/745 requirements.

2) Liaising with OM to obtain latest Technical Documentation periodically.

C. Audits

1) Assisting in planning and coordinating Supplier / OM's periodic evaluation audit.

2) Participating in Internal Audits, Supplier / OM's periodic evaluation audit and External Audit.

3) Compiling and maintaining audit files.

D. Design and Development

1) Communicating with OM to assess the feasibility of new designs or changes in existing designs.

2) Coordinating with cross-functional teams including Sales and Marketing, QA / QC / RA, to align design and development project objective.

3) Preparing design plan and monitoring project timelines.

4) Preparing sample requisition form for design and development (SRD).

5) Organizing review meeting with team members on every design and development stages.

6) Conducting verification and validation on design and development product for compliance.

7) Completing and maintaining design and development files.

E. Artwork Verification

1) Checking, reviewing and verifying labelling of the device packaging to ensure compliance with customer requirement and Applicable Regulatory Requirements.

2) Liaising with supplier / designer / OM for artwork amendment and conversion.

3) Liaising with customer for artwork amendment and approval.

4) Compiling and maintaining Artwork File.

F. Others

1) Participating in Risk Management Team.

2) Assigning GS1 barcode number for new item / changed item.

3) Assigning lot number for legal manufacturer's product.

4) Performing other work related functions as assigned by superior

Perks & Benefits

• Medical insurance
• Personal leave

QA Responsibility :

A. Documents Control

1) Assisting in managing quality document control system.

2) Preparing and revising Quality Procedures for process owner.

3) Preparing Document Change Notice.

4) Issuing document with identification of 'Master Copy', 'Controlled Copy', 'Uncontrolled Copy' and 'For

Training Purpose only'.

5) Updating and maintaining Document Master List and Records Master List and controlling the distribution of documents within the Quality & Regulatory Compliance Management System (QRCMS).

6) Maintaining Master Copy, Controlled Copy and Obsolete documents.

B. Technical Documentation

1) Assisting in composing and maintaining Technical Documentation in accordance with EU MDR 2017/745 requirements.

2) Liaising with OM to obtain latest Technical Documentation periodically.

C. Audits

1) Assisting in planning and coordinating Supplier / OM's periodic evaluation audit.

2) Participating in Internal Audits, Supplier / OM's periodic evaluation audit and External Audit.

3) Compiling and maintaining audit files.

D. Design and Development

1) Communicating with OM to assess the feasibility of new designs or changes in existing designs.

2) Coordinating with cross-functional teams including Sales and Marketing, QA / QC / RA, to align design and development project objective.

3) Preparing design plan and monitoring project timelines.

4) Preparing sample requisition form for design and development (SRD).

5) Organizing review meeting with team members on every design and development stages.

6) Conducting verification and validation on design and development product for compliance.

7) Completing and maintaining design and development files.

E. Artwork Verification

1) Checking, reviewing and verifying labelling of the device packaging to ensure compliance with customer requirement and Applicable Regulatory Requirements.

2) Liaising with supplier / designer / OM for artwork amendment and conversion.

3) Liaising with customer for artwork amendment and approval.

4) Compiling and maintaining Artwork File.

F. Others

1) Participating in Risk Management Team.

2) Assigning GS1 barcode number for new item / changed item.

3) Assigning lot number for legal manufacturer's product.

4) Performing other work related functions as assigned by superior

QC Responsibility :

1) Conducting inspection of incoming Raw Materials before dispatch for production.

2) Conducting inspection of Finished Products in accordance with documented procedures to conform to established specification before deliver to customer.

3) Completing and maintaining inspection activities' records for traceability purpose.

4) Identifying and segregating non-conforming material and product to prevent unintended use.

5) Reviewing and verifying Supplier / OM's Certificate of Analysis (COA) are conforming to the established specification before issuance of Certificate of Release (COR).

6) Issuing COR after reviewing of OM's COA for compliance.

7) Liaising with third party authority / laboratory for pre-shipment testing.

8) Reviewing and verifying external third party laboratory's testing report for compliance.

9) Reporting to QC Asst. Manager in the event of major variance in specifications / parameters.

10) Maintaining retained samples storage room in accordance with retention period.

11) Liaising with service provider to perform calibration of testing equipment.

12) Gathering and analyzing Quality Objective data for QC activities.

13) Participating in Internal Audits, Supplier / OM's periodic evaluation audit and External Audit.

14) Participating in Risk Management Team.

15) Performing other work related functions as assigned by superior.

Perks & Benefits

• Medical insurance
• Personal leave

Responsibility :

1) Involving Sales Admin Asst. Manager by handling administrative tasks, and managing sales documentation, Involves coordination between departments, maintaining accurate records and providing exceptional customer service.

2) Assisting Sales Admin Asst. Manager in preparing and processing PO.

3) Processing customer orders efficiently and accurately.

4) Handling customer inquiries and requests with professionalism.

5) Following with customers to ensure satisfaction and address any issues.

6) Maintaining accurate / up-to date / follow up order / shipment status.

7) Preparing / maintaining shipping document.

8) Ensuring all shipping documentation are completed and filed properly.

9) Updating WPR / records to ensure data accuracy and availability.

10) Collaborating with the respectively departments and or external parties to ensuring fulfilment of order/ shipment.

11) Performing general administrative duties, such as packaging online proofing, filling, and managing office supplies.

12) Coordinating with OM / OSP / Vendors / Service Provider as needed.

13) Performing other work related functions as assigned by superior.

Perks & Benefits

• Medical insurance
• Personal leave

Responsibility :

1) Supporting and Assisting the Sales and Marketing Assistant Manager in carrying out sales processing

and other related activities.

A. Sales Support

1) Performing the sales and marketing workflow, which includes booking new order, repeat orders, meeting customer needs and expectations, interpreting and designing the customer's product specification, the product's package design, packaging mock up and development.

2) Issuing contract order review, proforma invoice, container matrix study report, normal sales order,

customer specification, customer specification change notice, credit clearance checklist, Splenda report,

purchase order, indicative price, sample requisition and work progress report.

3) Handling inquiries and initiate negotiations to confirm orders and repeat orders before processing orders.

4) Updating all customer details in the Proforma Invoice and to inform admin user to update into the ERP system.

5) Creating cost certs for products if there are changes in the selling price and buying price.

B. Collaboration & Communication

1) Liaising with the Sales Admin department on the fulfilment of the customer's order delivery and shipment. To ensure customer expectations (orders) are well delivered to outsource manufacturing to manufacture in a correct and timely manner in alignment with specification and quality requirements.

Also monitoring customer packaging balance inventory from Sales Admin and reorder recommendations can be provided to customer based on the remaining stock levels.

2) Liaising with the Quality Assurance section on the customer artwork labelling requirement.

3) Liaising with the Quality Control section on the customer product quality and complaints (if required).

4) Liaising with the Regulatory Compliance section on customer product regulatory and registration

requirements.

5) Liaising with the outsourcing manufacturer on the customer's order's goods-ready date and request

a quotation for a new product (if required).

6) Liaising with the packaging supplier's to fulfil the expectations of customers for packaging design and artwork, mock up, sample print, and colour standard. Attend online proofing for a new project or improving an existing project with the packaging supplier. Request a quotation from the packaging supplier (if required).

7) Liaising with shipping agent/broker on availability of destination and freight cost for cost

estimation calculation purposes (if required).

8) Building and maintain strong relationships with customer.

C. Data Analysis & Reporting

1) Generate an analysis report in terms of customer sales performance.

D. Other:

1) Performing other work related functions as assigned by superior.

Perks & Benefits

• Medical insurance
• Personal leave

責任 ：

1) 協助維護公司監管事務和適用司法管轄區的醫療器材註冊和註冊維護。

2）協助維護監管文件的良好秩序。

3）審查和更新外部文件主列表，以及時了解監管法規和指南的變化。

4) 定期收集和更新監管註冊主清單，以反映最新的產品資訊。

狀態和監管資訊。

5）及時準備許可證及監理註冊申請及續約所需文件

方式。

6) 收集和協調信息，並準備監管文件以提交給

監管機構或商業合作夥伴。

7) 收集和協調訊息，並準備監管文件以供批准。

8) 與監管機構聯繫並安排監管文件的認可。

9) 協助審核從主管機關取得的相關產品註冊證書和許可證。

10) 協助識別需要發布諮詢通知/現場安全通知/現場安全糾正措施的事件/問題。

11）協助報告和警戒活動。

12）向客戶分發使用者回饋問卷並及時跟進。

13）收集和分析使用者回饋資料並編制使用者回饋分析報告。

14）協助準備監管審計。

15）參與內部審核、供應商/營運經理定期評估審核和外部審核。

16）參與風險管理團隊。

17）執行上級指派的其他與工作相關的職能。

福利待遇

• 醫療保險
• 個人休假

Tanggungjawab:

1) Membantu dalam penyelenggaraan Hal Ehwal Kawal Selia syarikat dan pendaftaran Peranti Perubatan Bidang Kuasa yang berkenaan dan penyelenggaraan pendaftaran.

2) Membantu dalam memastikan dokumen kawal selia berada dalam keadaan baik.

3) Menyemak dan mengemas kini senarai induk dokumen luaran, mengikuti perkembangan terkini dalam Perundangan dan Garis Panduan Kawal Selia.

4) Mengumpul dan mengemas kini Senarai Induk Pendaftaran Kawal Selia secara berkala untuk mencerminkan produk terkini

status dan maklumat kawal selia.

5) Menyediakan dokumen untuk penyerahan dan pembaharuan Lesen dan Pendaftaran Kawal Selia tepat pada masanya

cara.

6) Mengumpul dan menyelaras maklumat serta menyediakan dokumentasi kawal selia untuk diserahkan kepada

Pihak Berkuasa Kawal Selia atau kepada rakan kongsi komersial.

7) Mengumpul dan menyelaras maklumat serta menyediakan dokumentasi kawal selia untuk pengesahan.

8) Menghubungi dan mengatur pengesahan dokumen kawal selia dengan Agensi Kawal Selia.

9) Membantu menyemak sijil dan lesen pendaftaran produk berkaitan yang diperoleh daripada pihak berkuasa.

10) Membantu mengenal pasti insiden/isu yang memerlukan notis nasihat/notis keselamatan lapangan/tindakan pembetulan keselamatan lapangan.

11) Membantu dalam pelaporan dan aktiviti pengawasan.

12) Mengedarkan Soal Selidik Maklum Balas Pengguna kepada pelanggan dan menindaklanjutinya tepat pada masanya.

13) Mengumpul dan menganalisis data Maklum Balas Pengguna dan menyediakan Laporan Analisis Maklum Balas Pengguna.

14) Membantu dalam persediaan untuk Audit Kawal Selia.

15) Menyertai Audit Dalaman, audit penilaian berkala Pembekal / OM dan Audit Luaran.

16) Menyertai Pasukan Pengurusan Risiko.

17) Melaksanakan tugas-tugas lain yang berkaitan dengan kerja seperti yang diarahkan oleh pihak atasan.

Faedah & Kebaikan

• Insurans perubatan
• Cuti peribadi

Responsibility :

1) Assisting in maintenance of the company's Regulatory Affairs and applicable Jurisdiction Medical Device registration and registration maintenance.

2) Assisting in maintaining regulatory documents in good order.

3) Reviewing and updating external document master list, keeping up to date with changes in Regulatory Legislation and Guidelines.

4) Gathering and updating Regulatory Registration Master List periodically to reflect up to date product

status and regulatory information.

5) Preparing document for License and Regulatory Registration submissions and renewals on a timely

manner.

6) Collecting and coordinating information and preparing regulatory documentations for submission to

Regulatory Authorities or to commercial partners.

7) Collecting and coordinating information and preparing regulatory documentations for endorsement.

8) Contacting and arranging endorsement of regulatory documents with the Regulatory Agency.

9) Assisting in review the related product registration certificates and licenses obtained from the authority.

10) Assisting in identify incidents / issues which requires advisory notice / field safety notice / field safety corrective action.

11) Assisting in reporting and vigilance activities.

12) Distributing User Feedback Questionnaires to customers and following up in a timely manner.

13) Gathering and analysing User Feedback data and preparing User Feedback Analysis Report.

14) Assisting in the preparation for Regulatory Audit.

15) Participating in Internal Audits, Supplier / OM's periodic evaluation audit and External Audit.

16) Participating in Risk Management Team.

17) Performing other work related functions as assigned by superior.

Perks & Benefits

• Medical insurance
• Personal leave