QA Validation Contract

QA Validation Contract

Industry : Pharmaceutical

Role 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 Role 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.

Role Education & Experience:

• Science Graduate with minimum 5-year experience in Pharmaceutical Industry accredited by HPRA and FDA and a good understanding of regulatory requirements.

Location: Tipperary (Role would be based mostly on site – at least 3 days per week, but may be up to 5 days on site some weeks depending on project requirements)

Contract Duration: 6 months.