Senior Supervisor Validation - Career Growth Potential

Job Purpose

Responsible for the execution of equipment qualification, computer system validation, utilities qualification and qualification of Storage and Shipping system as per Validation Master Plan and in accordance with current regulatory requirements and company profile.

Key Accountabilities

1. To work together and assist the team with equipment qualification, storage and shipping qualification, utilities qualification and computer system validation activities.
2. To prepare validation protocols, analyze the results, compile the data and prepare summary report for utilities qualification, equipment qualification and temperature mapping for GDP.
3. To perform Computer System Validation consisting of Multi Data Report or Microsoft Excel Spreadsheets validation and Equipment software validation.
4. To co-ordinate with production, engineering, QC and warehouse departments for the execution of utilities qualification, equipment qualification, computer system validation and temperature mapping.
5. To ensure proper and complete validation/qualification documents are in safe keeping according to cGMP and GDPMD requirements.
6. To ensure data loggers are calibrated and kept safely.
7. Able to come in during weekends if qualification is planned.
8. Any other duties that may be assigned from time to time.

Job Requirement:

• Bachelor Degree (Hons) in Life or Applied Sciences. 
• 1 year working experience in pharmaceutical industry. 
• Working experience in any validation and qualification activities is preferred.
• Experience in Temperature Mapping for Storage Area/Chamber. 
• Experience in Hands-On Chemical / Pharmaceutical Laboratory Analysis.
• Understanding the GMP, GLP and GDP rules and guidelines.
• Proficient in MS Application