quality control or GMP laboratory experience in the pharmaceutical or
medical device industry?
Do you have managerial or team lead experience?
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 MICROBIOLOGY MANAGER - DUN LAOGHAIRE - DUBLIN
EMPLOYER
Our Client and the role will be based in their Dun Laoghaire plant.
The plant is one of the most dynamic in Ireland and is currently
undergoing rapid expansion and capital investment.
JOB DESCRIPTION
Overall responsibility for QC Microbiology Identification testing and
Clean Utility Monitoring. This role will also provide support testing
to the Environmental Monitoring and Product Testing groups within the
QC Microbiology Laboratory
Ensure the laboratory is operated in a safe manner
Develop and maintain quality systems within the QC laboratories to
ensure ongoing compliance to cGLP
Compliance with Standard Operating Procedures and Registered
specifications.
Provide an effective and efficient QC service by supervising,
developing and coaching the QC team.
Ensure timely completion of Laboratory Investigation Reports and
deviations through the Non-Conformance procedures.
Issue trend reports on investigations, non conformances and
Environmental Monitoring and identify laboratory practices and
procedures for further development/improvement.
Keeps abreast of current Corporate and industry requirements and
compliance trends as they pertain to laboratory operations and aseptic
manufacturing.
Approval of SOP’s, trend data, investigations, deviations,
validation protocols, reports, method validation/verifications and
equipment qualifications.
Participate in regulatory agency inspections.
Plan and implement procedures and systems to maximise operating
efficiency.
Manage and contribute to the achievements of department productivity
and quality goals.
PEOPLE MANAGEMENT
Supervision/Management of laboratory personnel and adjustments to
schedules to maximise efficiencies and adequately support production
and other departments.
Conduct performance appraisal reviews for laboratory colleagues and
identify training requirements for further development of colleagues.
Monitor and assist staff with work progress utilising lean standard of
work tools.
REQUIREMENTS
Bachelor’s degree in Microbiology or relevant experience
5+ years of biopharmaceutical QC experience or related quality control
or GMP laboratory experience in the pharmaceutical or medical device
industry.
Experience with regulatory compliance in cGMP manufacturing and
testing of pharmaceutical products.
Excellent written and verbal communication skills
Understanding/experience with Trackwise, Change Control Systems,
Documentation management system and SAP
Knowledge of applicable Regulatory requirements
Experience with Regulatory inspections desirable
Experience leading cross-functional teams desirable
Experience working with teams and influencing decisions
Have relevant years of experience in a pharmaceutical/healthcare
Laboratory or a related technical function preferably in an Aseptic or
microbiologically controlled environment.
Managerial/Supervisory experience with a proven record in a
Supervisor/ Team Lead role.
Strong background in microbiology and aseptic manufacturing is
required.
Possess key competencies to include planning/organisation, problem
solving, communication, teamwork, flexibility, coaching and
motivating.
PACKAGE
€ * - *K per annum -
open to negotiation for the right candidate
Flexi-time
Health plan for self & dependents
excellent pension plan
Annual performance related bonus
* days annual leave
Share options
We need : English (Good)
Type: Permanent
Payment: EUR 65,000 - 75,000
Category: Construction
