a Biopharmaceutical microbiology lab and worked in an aseptic
cleanroom performing Environmental Monitoring?
If interested, forward your CV to * or call
Karen on + *- * for a
confidential chat.
ASEPTIC QC MICRO ANALYST - **APPLY ON THE WEBSITE**/7 SHIFT - 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.
This role will support manufacturing operations on a **Apply on the
website**/7 shift pattern and may
include extended hours.
Specific Job Duties:
Act as aseptic guardian of Cleanrooms Grade A/B/C/D
Guiding and training junior members of staff
Act as delegate for shift lead/manager
Ownership of monthly & annual trend reports, readouts &
actions, including
presentation the EM trends during audits
Participate in audits, initiatives, and projects that may be
departmental or
organizational in scope.
Approve lab results
Initiate and/or implement changes in controlled documents.
Evaluate lab practices for compliance and operational excellence
improvement on a continuous basis.
General job duties:
Environmental Monitoring of Grade 8/9 Cleanrooms
Environmental Monitoring of Grade 5/7 Cleanrooms & Isolators
Reading of Environmental Monitoring Plates
Bioburden testing of water & disinfectants
Water sampling
Testing of In Process samples such as Protein Concentration, Density
& pHD
REQUIREMENTS
Bachelors degree in a science discipline
Biopharmaceutical QC experience in a microbiology lab
Experience with regulatory compliance in cGMP manufacturing and
testing of
pharmaceutical products
Experience working in an aseptic cleanroom performing Environmental
Monitoring is absolutely necessary
Preferred Qualifications
Proficient in the use of LIMS & LMES
Experience in a senior role, providing guidance to team members
Knowledge of related regulatory/industry considerations, compliance
issues
and/or scientific discovery
Experience with regulatory compliance in cGMP manufacturing and
testing of
pharmaceutical products
Competencies :
Technically strong background in microbiology and aseptic
manufacturing
Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an
advantage
Flexibility – the EM role often encounters changing priorities on a
daily basis
Problem solving skill
Experience with Regulatory inspectors and interacting with inspectors
desirable
Demonstrated ability to work independently and deliver right first
time results
Works under minimal direction
Work is guided by objectives of the department or assignment
Follows procedures
Refers to technical standards, principles, theories and precedents as
needed
May set project timeframes and priorities based on project objectives
and
ongoing assignments.
Recognizes and escalates problems
Auditing documentation and operation process
Demonstrated ability to interact with regulatory agencies
PACKAGE
3 - 5 years experience - ca € * - **Apply on
the website**K per annum + *% shift uplift (ca
€ *K per annum)
Benefits include performance related bonus, pension, VHI for family
and *- * days Annual
Leave + Public Holidays
Shift pattern will be 2 days, 2 nights (4 days off) rolling forward 1
day each week
We need : English (Good)
Type: Permanent
Payment: EUR 65,000 - 75,000
Category: Construction
