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