- Responsible for the supervision of the Microbiology Department and a team of microbiologists. Coordinate daily operations for a team of microbiologists and laboratory assistants; ensure that objectives are set, monitored, and completed in proper priority.
- Responsibility for the routine microbiological monitoring of starting materials, finished products and environmental control systems and routine testing where required. Responsible for the generation of documented procedures for Microbiological monitoring and responsible for compliance with documented procedures.
- Responsible for the identification and communication of adverse trends in routine microbiological monitoring
- Oversee sterilization testing and testing to support manufacturing and new product development.
- Consult on quality and microbiological issues, support problem solving and resolution, and provide quality management advice and counsel to customers for related laboratory testing needs.
- Your role will be to maintain regulatory compliance through established programs for lab testing, training, SOPs, and validation.
- Review and approve laboratory testing documentation.
- Facilitate, perform and review laboratory investigations.
- Assist in the creation and maintenance of laboratory SOPs and validation documents for GMP lab test procedures and systems.
- Assist in the writing of functional area status reports, regulatory documents, and process descriptions.
- Maintain environmental monitoring program.
- Maintain risk assessments required for parametric release.
- Management of lab equipment including, Qualifications, e.g. IQ/OQ, calibration and maintenance
- Participate in all GMP and operational training programs & complete associated Training Records
- Participate in internal and external audits (including regulatory)
- 3rd level Degree in Microbiology or relevant experience in a similar field
- 3rd level Degree in Microbiology or relevant experience in a similar field
- 5 years or more experience in a regulated pharmaceutical environment including people management experience.
- Experience of environmental monitoring and bacterial endotoxin testing
- Familiarity and understanding of FDA and EU pharmacopoeial requirements.
- Evidence of an acquired solid background of technical knowledge and experience, plus successful direction of significant projects
- Experience in supervising and motivating a team, project management experience and meeting deadlines.
- Excellent communication and interpersonal skills essential, proactive approach to work essential
- An ability to work independently as well as a member of a team in a dynamic, fast-paced environment essential
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Microbiology Lead - Ireland - Baxter Healthcare
Description
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
Microbiology Lead
GENERAL DESCRIPTION OF RESPONSIBILITIES:
EDUCATION REQUIREMENTS:
EXPERIENCE REQUIREMENTS:
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice #J-18808-Ljbffr
