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EN-DT00040
Job Summary
 
Job Type : any
Location : Bangkok Huay Khwang , Thailand
Salary (THB/month): 30 k - 50 k
Minimum Experience: 5 years
Education : Bachelor
EIT Job Id : EN-DT00040
Job Function :
QA / QC Engineer
QS
Open to :
Thai national Only
 

Quality Associate Officer (Medical / Pharmaceutical) 2months contract

Job Description
Our client is the global leader in the science of heart valves and hemodynamic monitoring. Now, more than 50 years later, the company has grown into a global company with a presence in approximately 100 countries and more than 7,000 employees around the world.

Role Purpose :
- The Quality Associate will be responsible for the key quality functions with in Thailand, support in warehousing activities, oversight in supply chain activities, implementation of Internal audit procedure and providing inputs in AP management review process.

Job Functions :
- Ensure that the Quality Management System (QMS) is effectively established, implemented and maintained to be in compliance with ISO13485,21 CFR820, and other relevant regulatory requirements.

Essential Job Functions ;
- Establish / Control / Ensure training on Quality Assurance Systems, policies, processes, procedures consistent with The company Global Policies ensuring that the quality of products are conform to established standards and regulatory requirements
- Responsible for Internal / External Audits, providing inputs in Quarterly Management Review for the region, to report out the performance of the quality system to Management with executive responsibility for review and any need for improvement
- Oversees Management and execution of Field Actions in the region / ensure notification to appropriate reporting channel of significant issues presenting significant health risk
- Establish and maintain the effective complaint handling process, under the company Quality Management System
- Responsible for Quality linked to Warehouse and Distribution for the region (mainly Third Party Logistic Companies).
- Responsible for the Management of CAPA for the country.
- Ensure evaluation / approval / control of all Edwards Lifesciences suppliers marketing product/services in the region by determining the risk level of supplied product / verification of Edwards brand guiding principles / performing supplier assessments.
- Ensure contract review requirements are met / approved for all Edwards suppliers in the region.
- mplement a robust process to better control and manage Distributors

Marginal Job Functions :
- Provides expertise and guidance in interpreting and implementing appropriate country regulations, agency guidelines and internal policies to assure compliance.
- Supports company goals and objectives, policies and procedures, QSR, and regulations.
Job Qualification
- Bachelor’s Degree or related Degree in Sciences , Pharmaceutical , Medical, Bio-Medical or related fields – preferably in medical expertise and Quality Management. An advanced degree (i.e. Master. PhD) is a plus.
- Excellent command of English , able to communicate with company global offices.
- Minimum 5 years professional experience in Quality Management in a Medical or Pharmaceutical Quality environment
- Solid understanding of Quality Systems in manufacturing site
- Experience of working with US companies / exposure to US environment.
- Adequate knowledge in ISO 13485, 21 CFR 820, 21 CRF 11, the relevant regulatory requirements in country, and all other applicable requirements
- Knowledge in process validation and risk management
- Experience of FDA Inspection / Local Inspection preferred.

Working location: Rama 9 Road
Working Hour: Monday- Friday 8.30-17.30
Benefits:
- Medical & Health Insurance
- Bonus depend on company’ s profit

"Must Have" in Candidate qualifications


- Did you graduate in Bachelor’s Degree or higher in Sciences , Pharmaceutical , Medical, Bio-Medical or related fields ?
- Do you have an excellent in English able to work with Regional Companys’ Branches?
- Do you have min 5 years experience of Quality Management in a Medical or Pharmaceutical Quality environment?
- Do you have knowledge in in ISO 13485, 21 CFR 820, 21 CRF 11?
- Do you have Experience of working with US companies/exposure to US environment. Preferably with some experience in a manufacturing site ?