Responsibilities:

• Develop and execute validation (IQ/OQ/PQ) / study protocols as performer or witnessed by (depending on assignment) against approved URS and risk assessments. 

• Complete the executed test package with summary report.

• Lead or support risk assessments and impact assessments where applicable.

• Initiate change control process for any modifications affecting validated state.

• Plan, manage and coordinate activities with other functions including equipment suppliers, Engineering, Manufacturing, QC, QA, and Automation/IT.

• Track the CQV deliverables and ensure adherence to schedule from project to operation readiness.

• Ensure traceability across lifecycle documents

• Lead or support resolution of variation / deviation investigation in a timely and compliant manner.

• Support administrative, periodic review and document revision related work.

About You:

• At least bachelor’s degree or above, preferably in Engineering or Science discipline.

• Candidate should have at least one year of hands-on CQV experience in the equipment qualification for example autoclave. 

• Working experience in supporting smoke study and / or aseptic process simulation is preferable. 

• Strong analytical and problem-solving skills. 

• Strong time management, communication and collaboration skills. 

• Candidate with experience in regulatory inspection by FDA / EMA will have added advantage. 

• Strong understanding in Data Integrity requirement (ALCOA+ principles) and Good Documentation Practice. 

Duration: 6 months