22609-QC Associate Microbiology Specialist-Carlow Contractor NEW

This is an 11-month initial contract.

Purpose 

You will provide technical support to the QC Microbiology Lab & operations to ensure the continued manufacture and supply of quality pharmaceutical products in meeting the 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.

You 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 is required for this role.

Responsibilities 

• Development and execution of Microbiology test methods and project validations.
• 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.
• Ensures highest safety standards.
• May be required to perform other duties as assigned.

Qualifications

• Bachelor’s Degree or higher preferred; ideally in Microbiology or a closely related discipline.
• 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.
• Strong Planning and Organising skills
• In-depth knowledge of the veterinary market
• In depth knowledge of pharmacovigilance legislation and guidelines
• Wide-ranging and sound communication skills
• Ability to work well within in a high performance team structure
• Ability to work under pressure to deadlines
• Sound interpersonal skills for dealing with a wide range of people in a variety of situations
• Ability to communicate (verbally and in writing) clearly and succinctly
• Self-starter with drive and focus
• Sound commercial acumen with high levels of integrity and trustworthiness