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
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.
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