Title:  Trainee - Quality Validation

JOB PURPOSE:

Trainee to learn and support the validation/qualification initiatives to internal project teams and external validation firms in order to ensure schedules are met and that systems, both computer and equipment are in compliance with regulatory requirements.

KEY ACCOUNTABILITIES:

·       Perform temperature and Humidity Mapping studies for warehouses, stability chambers & refrigerators and prepare related protocols with mapping reports.

·       Arrange with external calibration agencies to keep tools ,weights & balances within calibration due dates.  

·       Preparing process validation protocols and arrange of process validation activities

·       Prepare process validation reports

·       Conduct periodic environmental monitoring activities to maintain quality and pharmaceutical regulatory standards

1.        Air particle count test

2.       Air smoke test

3.       HEPA filters integrity test

4.       Air velocity

5.       Recovery time study

6.      Air change

·       Perform requalification for sampling booth & QC lab cabinets.

·       Arrange training files.

·       Arrange validation documents approval between departments.

Minimum Qualifications:

• Bachelor’s degree in Chemical Engineering, Science or any related field.
• Familiar with computer & office app
• Familiar with cGMP. 
• Very good in English writing & speak

Minimum Experience: 0-1 year of experience working in Engineering or related Quality fields.

Training period: One year/ Paid