Job Description 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