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Associate Quality Specialist - Microbiology

Employer
HERO Recruitment
Location
Carlow
Salary
Competitive
Closing date
19 Jun 2023

View more

Sector
Biomedical Science
Role
Specialist
Contract Type
Contract

Associate Quality Specialist – Microbiology

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 authorisation, 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 organisation. 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 optimisation/redevelopment.
Authoring and managing change controls, procedures, test methods and deviations.
Result authorisation 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.

For further information on this role in Software Engineering please contact Maraleeze on or (phone number removed)

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Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

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.

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