Qa Validation Engineer

Description:

The role is mostly on-site – there could be scope for a small amount of remote work, but most weeks would be fully on-site, especially during the execution and review of protocols.

Summary: QA Validation role to ensure Qualification of Equipment / Computerised Systems / Facilities and Utilities is performed in compliance with regulatory requirements, company policy, and procedures.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Review of Qualification / Re-Qualification, and Validation activities for Equipment / System / Facility and Plant Utilities as QA Validation.
• Support execution of Qualification / Re-Qualification and Validation activity
• Review and approval of Project validation plans.
• Co-ordinates with manufacturing/engineering personnel for respective Qualification / Validation / Re-qualification activity for timely completion of activities.
• Investigates any deficiencies related with qualification activities and determines corrective actions.
• Review of SOPs and Drawings as related to validation.
• Review and approval of calibration and PM activities (e.g., schedules) and Work orders as related to validation.
• Review and approval of studies/risk assessments/investigations related to Qualification
• Participates in any investigations that may impact the qualified state of equipment, systems, facilities, or utilities.

Education & Experience:

• Science Graduate with minimum 5 years of experience in the Pharmaceutical Industry accredited by HPRA and FDA