QA Validation Engineer

Job Spec for QA Validation Contract

Contract for 6\-12 months.

Role is mostly on site – could be scope for small amount remote, but most weeks would be fully on site especially during 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 activity of 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\-year experience in Pharmaceutical Industry accredited by HPRA and FDA