QA Validation Engineer

Tipperary - Ireland

Monthly Salary: Not Disclosed

Posted on: 8 hours ago

Vacancies: 1 Vacancy

Job Summary

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

Job Spec for QA Validation ContractContract 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 System...