Design Development Laboratory Officer

1. Support stability study: New product and Asia to Asia project (40%)

2. Manage stability samples (i.e. Prepare labeling, Take the samples in/ out chamber, provide stability sample to QC-Lab for Microbial testing, Send sample to External lab (if need))

3. Perform stability study testing of each time point both NPD, Asia to Asia project (i.e. Appearance, Peel adhesion, Extensibility, permanence set)
4. Coordinate and gather sample for stability from Production and Validation team
5. Handling on stability chamber (i.e. monitoring and record for stability chamber, Add DI water in chamber, Issue CAR and investigation in case the chamber condition is OOS, check calibration due and inform supervisor when it is nearly due date)
6. Stability report preparation
7. Design selection testing for new product / Comparison test / Special test (30%)
8. Perform design selection study testing (i.e. DOE sample / prototype testing)
9. Perform testing to support specification setting (i.e. Control specification, Claim justification/ Rationale formulation)

2.Material qualification and test support for new product and Asia to Asia project (10%)

Support Prototype (10%)

• Onsite for prototype activity and Collect prototype from production for Design selection testing
• Received and check material sample (without code number)
• Issue NCP for Material, during prototype production
• Request Performa invoice and Process parcel shipment via DHL for sending prototype abroad

Transportation study support (5%)

• Preparing sample for transportation testing
• Coordinate with external laboratory for send/ receive samples

Other Support to Department (5%)

• Gather all requested RM/ SFG/ FG from QC incoming/ WH
• Execute on D&D laboratory activities (e.g. Manage D&D BOI waste and update control log)
• Update control log of D&D material sample
• Support D&D documentation (e.g. WI, SOP)
• Other responsibilities that are assigned by her / his manager. (e.g. Issue PR for any request, Performa invoice and Process parcel shipment via DHL for sending stability samples to URID/ External Laboratory (if need)
• Support and cooperate in the preparation of environmental systems.
• Support and cooperate in complying with the requirements of good distribution practices for importing or selling medical devices

Characteristic (คุณสมบัติที่จำเป็น):

1. Education (การศึกษา): Bachelor's degree in applied science or related field.

2. Competency (ทักษะความสามารถ):

·      Computer skills (MS Words, Excel, Power point, Internet and others).

·      Fairly understand both writing and speaking in Thai/ English

·      Good project handling.

·      Understanding process validation and routine control.

·      Understanding requirement of ISO 13485 standard, GMP or other standard/ regulation for medical device and can provide or prepare the related document.

·      Knowledge of laboratory activities (e.g. calibration technique, lab testing)

·      Knowledge of problem solving, decision making

·      Knowledge of Quality Control and Statistical Techniques i.e. Minitab. (Nice to have)

·      Knowledge of Microbial and analytical testing. (Nice to have)

·      Knowledge of QMS (e.g. Investigation techniques and CAPA handling) (Nice to have)

3. Training (การฝึกอบรม):

ISO 13485, ISO 14001, EU-MDR, Risk management (ISO14971), GMP, GDPMD, Company regulation, QC/QA technique, Internal audit, microbial and analytical testing, product knowledge, investigation techniques and problem solving, communication skill, calibration, validation and verification, process control and decision making

4. Experience (ประสบการณ์): minimum 2 years on experience in manufacturing, laboratory environment, and/or medical device filed

Working hours : 5 days work week

Welfare and Benefits

• Provident Fund

• Staff training and development

• Fuel/transportation fees

• Marriage gift

• Social security

• Health insurance , Accident Insurance

• Ordination leave

• Employee's uniform

• Funeral payment support

• Annual trip or party

• Annual bonus

If you aim to challenge yourself with opportunity to show your ambitious and skill. We are ready to welcome.

Interested candidates are invited to submit application via APPLY NOW

Urgo Healthcare Products Co., Ltd.

154 Moo 5, Tiwanon Road,T. Bangkadee,

A. Muang Pathumthani, Pathumthani