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Job Description

Microbiology Analyst

About the role:

The QC Microbiology Analyst performs environmental monitoring (EM) and microbiological/analytical test methods on important utilities, raw materials, in-process intermediates and varying stages of drug products and within cGMP guidelines, to support manufacturing of biologics product at Takeda Ireland Ltd, Grange Castle. The Microbiology laboratory is based in the P3 production building.

Onsite work mode.

How you will contribute:

• Facilitate incoming sample receipt
• Build microbiological and analytical methods to facilitate in-process testing and final release testing such as Endotoxin, Mycoplasma, and Sterility supporting the release of biologics product.
• method validation/suitability
• Perform environmental monitoring sampling and testing of facilities, equipment, and important utilities supporting the manufacture of biologics product. Evaluate completed assay validity, calculate and summarise results, analyse data per expected or specification ranges.
• Compilation and verification of trend analysis reports.
• Monitor and control of laboratory supply and important reagent inventories.
• Perform growth promotion of media and microbial identification testing.
• Exhibit upon occurrence of compliance risks and deviations from laboratory procedures; perform initiation of investigation records within required timeframes.
• Provide input support to the progression of test method validation, investigations, technical studies, and method transfer protocols.
• Perform other responsibilities as deemed necessary
• Oversee aseptic practices (gowning, monitoring, cleaning and related training).
• Develop and collaboration between the Microbiology laboratory and operations.
• Train other microbiology analysts
• Ensure that testing schedules are achieved and manage laboratory resources (instruments and personnel) to provide a comprehensive analytical service for testing of all samples.
• Participate in the technical transfer / validation of microbiological testing procedures including Mycoplasma, Sterility testing and Endotoxin testing
• Participate in cause analyses (RCA) as part of investigations into any non-conformance, instrument malfunction, accident or other abnormal occurrence.
• Ensure that any Out of Specification (OOS) or Out of Trend (OOT) analytical results are managed following SOP.
• Prepare documents.
• Prepare for, and support, internal and external audits (e.g. HPRA, FDA, corporate).
• Support projects, quality programs and continuous improvement programmes within the Quality department and in other departments.
• Maintain standards of safety to guarantee a safe working laboratory. Ensure that the laboratory is kept clean, tidy and safe.

What you bring to Takeda:

• Degree in Microbiology or other relevant field.
• 1 or more years' experience working in Microbiology in the pharmaceutical industry, preferably in a Biologics company knowledge and practical experience in aseptic techniques and working in Grade A/B facility.
• Experience of microbiology testing including Sterility, endotoxin, mycoplasma and Environmental Monitoring
• Knowledge of GMP and current FDA & EMEA regulations
• Experience of Lean Laboratories is preferable
• Excellent organizational skills
• Good Microbiology knowledge
• Meeting established timelines.
• Knowledge of cGMPs.
• Successful track record in achieving goals as part of a team within a growing,
• Demonstrated to support a growing organisation.

What Takeda can offer you:

Full Healthcare Cover - includes dependents

Pension Scheme

Attractive Bonus

Subsidised canteen

Parking facilities with electric car charging points

Health & Wellness programs including onsite flu shots and health screenings

Educational Assistance

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.

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