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Sterility Assurance Microbiologist

Req #: 170005E5_en
Location: Dublin, L IE
Job Category: Quality
Date Posted: 8/11/2017 10:45:19 AM
Baxter International


Sterility Assurance Microbiologist is responsible for the quality assurance oversight of the microbiology laboratory and implementation of sterility assurance best practice requirements




The Sterility Assurance Microbiologist is accountable and responsible for the following activities:


·         Responsible for development, management and trending Environmental Monitoring (EM) program;

·         Provide coaching to other functions/sites in using problem solving structured approach;

·         Support and lead risk reduction and continuous improvement initiatives in line with company strategy;

·         Support and lead problem solving investigations for product and process deviations or customer complaints;

·         Responsible for deviations investigation and documentation associated with Corrective and Preventive Actions;

·         Proactively identify and escalate opportunities for risk reduction and Continuous Improvement;

·         Act as Change Leader for key projects;

·         Oversight of microbiology laboratory in routine and non-routine product testing and environmental microbiological testing.

·         Perform microbiological validations as needed for products and processes

·         Ensure products and processes comply with procedures and the principles of GMP

·         Support and assist in internal and external audit program. Participation in regulatory and corporate / internal audits and performance of supplier audits(as required), including documentation review.

·         Conduct training of Quality and Manufacturing personnel

·         Development of quality system procedures, controlled documents and processes

·         Risk Management of the quality system and processes

·         Support facility projects including process development and quality improvement initiatives

·         Ensure site-wide local systems are in compliance with Baxter and Regulatory requirements

·         Compliance to Environmental Health & Safety (EHS) requirements

·         As the Function sterility Assurance (FSA) representative support  the Regional Sterility Assurance personnel with respect of global sterility assurance commitments



·         Degree in Science with a speciality in Microbiology

·         Post qualification experience of at least 5 years

·         Previous experience in an aseptic manufacturing facility

·         Working in a project based environment


2.0               SKILLS


·         Have excellent inter-personal, organisational, leadership/management and communication skills.

·         Be a passionate advocate of quality as a discipline and continuous improvement

·         Have experience in the use of quality improvement and problem solving tools (Failure Modes & Effects Analysis (F.M.E.A.), Capability Studies, Process Mapping, DMAIC, PDCA, etc…), and the interpretation of data

·         Have experience of critical equipment and process Change Control

·         Have experience in microbiology and associated validations and processes

·         Capability to work in autonomy

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