Job Description

The QC Senior Specialist  will support the QC department in Athlone.

This role will be responsible as an SME on
microbiological product testing and environmental monitoring with
responsibility for management of QC quality system records including deviations
and laboratory investigations, report writing, generation and presentation of
QC metrics and environmental monitoring trends to QC and site leadership. This
role will also be responsible for coordinating and completing QC batch review.

You will be responsible for:

•            Ensuring
high cGMP, GLP standards are maintained and adherence to schedules and targets
to meet regulatory and business requirements.

•            Supporting
and coordinating validation/Qualification of Microbiology test methods

•            Generation
of annual environmental monitoring reports

•            Lead
and participate Quality Risk Assessments relating to the Microbiology.

•            Maintain
regulatory compliance through the creation and maintenance of programs for
laboratory testing, training, SOPs and validation.

•            Preparation
of documentation for audits carried out by internal auditors and Regulatory
bodies.

•            Represent
the Microbiology department in internal and external audits where appropriate
and be responsible for the completion of actions/ recommendations identified
from both internal and external audits.

•            To train
laboratory personnel and play appropriate role in the development, operation
and evaluation of training/re-training programs

•            To maintain
competence and keep up to date with all new technologies, procedures and
methods used in the Microbiology Laboratory.

•            Investigate
out of specification/limit results utilizing Root Cause Analysis tools in
conjunction with the Microbiology Laboratory Manager, QA and other relevant
departments and to implement effective corrective and preventative actions
while ensuring all investigations are closed with the specified lead-time.

•            Perform
technical review of data generated in laboratory, validation protocols and
reports.

•            Scheduling
of testing, review and authorization of microbial data.

•            To
represent the Microbiology laboratory at internal and external meetings.

•            Provide
Technical support to Manufacturing and Projects which the company undertakes
through project participation, investigation, validation and testing activities
and prepare Technical Reports as required.

•            To
keep management updated on issues arising within the laboratory.

•            Provision
of trouble shooting and similar expertise in the resolution of laboratory
issues as they arise from time to time utilizing Root Cause analysis tools

•            Identify
and implement initiatives designed to improve the efficiency of the laboratory
function/department.

Requirements

You will need to have:

•            Minimum of 5 years of experience in cGMP Quality
environment.

•            Degree in Microbiology or related Science.

•            A high degree of technical competency in Sterility
Assurance, Aseptic filling and microbiology methods.

•            Good
knowledge of current regulatory requirements for Microbiology / Sterility
Assurance in support of cGMP operations supporting clinical and commercial
manufacturing.

•            Subject Matter Expert in Method Validation, Endotoxin and
Bioburden testing

•            Ability
to develop collaborative relationships with other functions and sites in order
to achieve functional, site and company goals.

•            Excellent problem solving and root cause analysis skills.

•            Routinely
takes an innovative approach in developing processes and procedures that are
both efficient and compliant.

•            Strong organizational skills.

•            Excellent written and oral communication skills.

We would prefer for you to have:

•            Experience in Quality Risk Management.

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