Summary: 

To support commissioning, qualification, and validation (CQV) for a commercial pharmaceutical manufacturing site. The incumbent will plan, execute, and document validation activities per GMP requirements from applicable regulations and company SPO, ensuring equipment and all other processes are fit for intended use and remain in a validated state throughout their lifecycle.

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 resolution of variation / deviation investigation in a timely and compliant manner.

• Provide training/knowledge transfer and share best practice experience to colleagues. 

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

• Qualification of clean air equipment, controlled temperature unit (CTU), sterilization cycle (CD, PQ) of autoclave loads, thermal / thermostatic / insulated shipping box and any other qualification area, where required

About You:

• Bachelor degree preferably in Engineering or Science discipline.

• At least 5 years of hands-on CQV experience in the validation area.

• Possess good communication, interpersonal and problem-solving skills.

• Able to adhere to timeline provided.

• Good knowledge in cGMP, cGDP and ALCOA+ principles.

Duration: 6 months

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