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Job ID: JOB-13638
Quality Specialist– Microbiologist

Location – Carlow

Length of contract –  9 months 

Job Purpose:

To provide technical support to the QC Microbiology Lab & operations to ensure the continued manufacture and supply of quality pharmaceutical products in meeting the Merck Manufacturing Division (MMD) priorities of: Compliance, Supply, Strategy and Profit Plan. This role holds more senior responsibilities within the Microbiology Laboratory including (but not limited to) documentation development, report writing, execution of method and equipment validation, drug product result authorization, providing microbiological support for site, performance of bench experiments as required. The ideal candidate will be capable of self-management and decision making and will demonstrate a high level of leadership, initiative, collaboration, and coaching to facilitate the team in becoming a high performance organization. Central to this objective will be the active engagement and communication with all internal (e.g. QC Analytical, Tech Ops, IPT, QA) and external (e.g. Microbiology COE). A high level of innovation, enthusiasm and drive will be required to deliver technical excellence in required for this role.

Key Responsibilities:

•Development and execution of Microbiology test methods, Method Validation and Method Qualification, mainly bioburden, endotoxin and Sterility test methods.

• Troubleshooting of issues which arise during the execution of validation studies and routine tests.

• Development of training modules.

• Microbiology Support to Site Investigations

• Driving Continuous Improvement initiatives, including lean lab initiatives, method optimization/redevelopment.

• Authoring and managing change controls, procedures, test methods and deviations.

• Result authorization for microbiological samples to support batch release.

• LIMS System updates

• Assessing compendial and quality manual updates pertaining to the Microbiology Lab & environmental control.

• Supporting lab stock management and financial control as required.

• Supporting the environmental control program by trend analysis and implementation of appropriate corrective and preventative measures.

• Understands and applies regulatory / compliance and compendial requirements to their role together with remaining current on upcoming regulatory and compliance changes.

• Interprets customer needs, assesses requirements and identifies solutions to non-standard requests.

• Makes decisions within guidelines and policies which impact microbiology projects. • Ensure highest safety standards.

• May be required to perform other duties as assigned.

Required Qualifications:

Education :

• Bachelor’s Degree or higher preferred; ideally in Microbiology or a closely related discipline.

Experience :

• Demonstrated change management skills (CEM) with continuous improvement.

• Strong knowledge in execution, validation and development of microbiology related test methods i.e. Bioburden, Endotoxin and Sterility testing.

• At least 5 years’ experience in the Microbiology Pharmaceutical industry or a similar operating environment.

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. 

They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

For further information on this role please contact Maraleeze on 086 4410614 / recruit@hero.ie 

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

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Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Maraleeze Keane

JOB-13638

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