working in the pharmaceutical or biotechnology industry as a Subject
Matter Expert providing quality direction of introduction of
automation / IS projects?
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.
SENIOR QA ANALYST - QA AUTOMATION TECHNICAL SUPPORT - 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.
The Quality Assurance Technical Support (QA TS) Specialist is a senior
position within the QA function which will typically report to a QA
Mgr or Senior Manager and will be required to be a Subject Matter
Expert in their assigned area of responsibility.
Accountable for Quality oversight of processes and procedures related
to IS, CS & Automation compliance (ex: BMS, PCS, FMS, HMI upgrades
etc..)
Quality review and approval of C & Q documentation
Review of Risk Assessments, DS, URS & QRAES documents
Review of validation Plans, Protocols, IQ, OQ, PQ and associated
validation documents
Review of executed validation documents and reports
Perform all activities in compliance with Amgen safety standards and
SOPs
Support a safe working environment by complying with all pertinent
environmental health/safety practice, rules and regulations.
Provide Quality direction and input at Change Control and Deviation
Review Boards and assume QA oversight of change control and
Deviation/CAPA records; ensuring scope of record is clear and
implementation activities are robust and timely.
REQUIREMENTS
University degree. Science or Engineering related discipline
preferred.
Relevant experience (7 yrs +) working in the pharmaceutical or
biotechnology industry as a Subject Matter Expert providing quality
direction of introduction of automation / IS projects
Ability to work independently and remotely with minimum direct
supervision.
Critical thinking skills.
Strong organisational, communication, coordination, and meeting
facilitation skills.
Independent, self-motivated, organized, able to multi-task in project
environments and skilled in communication and collaboration.
Team player prepared to work in and embrace a team-based culture that
relies on collaboration for effective decision-making.
PACKAGE
Contract role
Hourly Rate € * - € *
per hour
Minimum * month contract
We need : English (Good)
Type: Permanent
Payment: EUR 55 - 65 Per Hour
Category: Construction
