Skillpower Services (Thailand) Co., Ltd.

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Sep 6, 2024

Quality Assurance and Regulatory Affairs (QA/RA) Manager/85K/SRT Red Lines Laksi

สถานที่ปฏิบัติงาน

Lak Si, Bangkok

เงินเดือน

85,000

อัตรา

สมัครงาน

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Job Descriptions

QA/RA Manager (Medical supplies, Medical equipment and Medicine) QA: QA activities including Quality assurance, Document control center and Quality system management to ensure that all working processes are complied with regulatory requirement and quality standard. To ensure compliance to quality system procedures relating to CAPA, non-conformances, complaint handling, internal auditing, risk management, adverse event reporting and product field actions through development maintenance and adherence to documented processes. RA: RA activities pertaining to product registration as per regulatory requirements such as product registration, amendment and promotional materials submission as assigned, ensuring strict compliance to the FDA’s regulations. Prepares and follow up regulatory submissions to ensure the timely registration of new products and maintain existing registrations. Liaises with company affiliates both locally and internationally on regulatory issues. Also lead the regulatory filings and maintain registrations in various countries. Educating and training team to become professional. Working Date: Monday-Friday (09.00-18.00) Location: Vibhavadi-Rangsit road, Laksi (Near SRT Red Lines Laksi)

Qualifications

Male or Female, aged between 30-45 years old
Bachelor’s degree in related filed
Minimum 5 years working experience in quality assurance, regulatory affairs area, and management (experience in medical product in an advantage)
Have good experience in working with FDA in preparation of documents for the product registration until product marketing approval.
Understanding of the rules and regulations medical products.
Knowledge of relevant regulatory requirements and standards for medical devices (FDA, ISO13485, ISO 9000, 21 CFR 820, ISO14971, GMP requirements etc.)
Leadership Character can work under high pressure
Strong problem-solving and prioritization skills
Good command in English (speaking, reading and writing)
Good at computer skills (MS Office, MS Excel, Adobe etc.)

BenefitsSee all Benefits.

How to apply

- สมัครผ่าน JobThai แนบ Resume ด้วยนะครับ - ส่งใบสมัครทาง Email - มาสมัครด้วยตนเองได้ที่ ตึกยูไนเต็ด สีลม ชั้น46 Walk in interview Time :Mon - Fri 9.00 – 11.00 AM - 14.00 - 16.00 PM Manpower At Unit 4606 Floor 46th ,United Center Building.

Contacts

ฝ่ายทรัพยากรบุคคล

Skillpower Services (Thailand) Co., Ltd.

Unit 4606 Floor 46th United Center Building 323 Silom Road,

Si Lom Bang Rak Bangkok 10500

Tel. : 02-631-0464

Email : manpowser14_1028@trustmail.jobthai.com (Email for job application & inquiry)

Website : https://www.manpowerthailand.com/

Location

On Vibhavadi Rangsit road, close to SRT Red Lines Laksi

Talat Bang Khen Lak Si Bangkok

Application Methods