Records e.g. Deviation Records, CAPA, ARA and Change Controls in the
pharmaceutical or biotechnology industry?
This is a contract role based in Dun Laoghaire, Dublin.
If you have the relevant experience, please forward your CV to **Apply
on the website** for review or call * **Apply
on the website** to discuss in confidence.
QC SYSTEMS ANALYST - BIOTECH INVESTIGATIONS - DUBLIN
JOB DESCRIPTION
Our client is a leading international Biotechnology company with a
state of the art aseptic manufacturing facility in Dun Laoighaire,
South Dublin.
The plant is one of the most dynamic in Ireland and is currently
undergoing rapid expansion and capital investment.
This is an excellent opportunity to get experience into
Ireland&# *;s leading aseptic manufacturing
plant.
QC Systems Senior Associate Investigations is a key member of the QC
Systems team.
They provide support to the QC function for all activities within the
site Quality System associated with QC Deviation Investigations, CAPA
records, Analytical Results Assessments (ARA) and Change Controls.
The successful candidate will own and manage the end-to-end life cycle
of Quality records on behalf of Quality Control.
The role has a strong focus on technical writing and problem-solving
including Root Cause Analysis and 5 Why methodologies.
Triage Management
Quality Record owner
Technical writing for investigations
Ensure timely closure of Quality Records
SME for Root Cause Analysis and 5 Why methodologies
Development of robust CAPA and CAPA Effectiveness Verification in
conjunction with area SMEs
Trend Analysis of QC Quality records
Monthly Metrics Management and Reporting
Participate in cross functional Investigations Teams
Lead Continuous Improvement Initiatives
Contribute to success of QC Goals
Support NPI/ Lot Release / Stability linked to Quality Records
Participate in Regulatory Inspections
Ownership of Change Controls Key Values and Competencies:
Work in Teams; Ensure Quality; Be Science Based; Collaborate,
Communicate and Be Accountable
Ability to work through Complex Problems
Excellent verbal and written communication skills including technical
writing, presentation, and facilitation skills.
Ability to work in a fast-paced environment with changing priorities
Comfortable working under minimal direction
REQUIREMENTS
Hold a third level qualification in a science related discipline
Have a minimum of 4 years experience in Biopharmaceutical/
Pharmaceutical industries or 2 years in a similar investigator role
Experience owning Quality Records e.g. Deviation Records, CAPA, ARA
and Change Controls advantageous
Possess key competencies to include planning/organization, problem
solving, excellent verbal and written communication, teamwork,
flexibility and adaptability
PACKAGE
Contract role - Hourly rate € * - €**Apply
on the website** per hour
Minimum * month contract
We need : English (Good)
Type: Permanent
Payment: EUR 30 - 36 Per Hour
Category: Construction
