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Your Big Idea PDF
Your Big Idea PDF
Your Big Idea PDF
Specialist
Harseerat Rataul
Employment history
Clinical Pharmacist and Pharmacy Assistant and
Clinical Data Coordinator Quality Packaging
Sep 2012 - Dec 2014 Analyst
Oct 2015 - Aug 2018
Pharmacovigilance
Associate
Dec 2014 - Sep 2015
Objectives of the role
CONTINUOUS AUDITING
Engineering the start
Understanding Communication/
Collaboration PDCA cycle
the QMS
CAPA KPI’s
Gap analysis
(deviations) (ISO 9001:2015)
Key challenges of the
role:
● Facilitation of procedures ● GDP Training
● Appropriate (Directive
documentation 2001/83/EC)
● Implementing strategies ● Due Diligence
at elementary level ● Liaising with
operations
Strengths Support
https://www.hse.ie/eng/about/qavd/patient-safety/
https://www.hpra.ie/docs/default-source/publications-forms/guidance-docum
ents/ia-g0011-guide-to-control-and-monitoring-of-storage-and-transportation-co
nditions-v2.pdf?sfvrsn=18
Thank you