PURPOSE OF THE POSITION
Reporting to the QA Ops/QC Lead, the Senior Analyst is a key member of the quality control team with focus on microbiology, in ensuring effective delivery of the microbiology function within an aseptic sterile environment.
KEY RESPONSIBILITIES
Testing
Conduct sterility and bioburden testing in line with microbiology schedule and as per instructions and ensuring all testing is fully recorded and reported.
Environmental monitoring
Conduct environmental and water monitoring tests as required by the microbiology schedule and in line with standard operating procedures
Manage laboratory
Set schedules for the microbiology lab and ensure schedule adherence for all analysts.
Track, record and report the use of laboratory equipment including consumables and ensure we have the required stock levels at all times. Ensure all laboratory equipment is maintained in good order and adheres to the asset management programme.
Contribute to quality control and micro laboratory
Make a positive and effective contribution to the quality control team and fully engage to ensure the laboratory is operated in a safe manner with full compliance to Standard Operating Procedures and registered specifications
Quality Systems
Develop and maintain quality systems within the laboratory to ensure ongoing compliance with cGLP.
Development and updating of SOPs, validation protocols, validation reports and method validation / verifications and equipment qualifications.
Ensure timely investigation, reporting and review of any laboratory investigations and out of specification results.
Execute periodic trend reviews.
Non routine testing
Conduct and complete any non-routine testing as requested by the QC Lead including any non-routine studies that are required.
Cross functional involvement
Work closely with other members of the organisation to ensure successful delivery of key project initiative with a clear focus on continual and sustained improvement
Maintain working knowledge
Keep abreast of current industry requirements and compliance trends as they pertain to laboratory operations and aseptic manufacturing and through regular effective communication share this knowledge and information within the organisation.
Champion For Contamination Control Strategy
Champion for the site contamination Control Strategy through Gemba, process improvements and mentoring in aseptic behaviours
COMPETENCIES
Forward Thinking & Strategic Planning
Collaboration & Knowledge Sharing
Responsiveness
Achievement through People
Relationship Building & Customer Ethos
Results Orientation
Commercial & Market Insights
Openness & Leading Change
Innovation & Creativity
Technical expertise
SPECIFIC SKILL REQUIREMENTS
Minimum of 3 years’ experience within a microbiology or laboratory environment .
Experience delivering technical training is a distinct advantage is desirable.
BS Degree in Microbiology or other related discipline
Self-initiating / self-directed
Problem solving ability using robust tools.
English is essential
Technical Skills
- Strong analytical/quantitative skills
- Good computer skills with high proficiency in Microsoft Office a plus
- Thorough understanding of quality systems and cGMPs.
- Experience handling Environmental and laboratory investigations
Legal statement as below
This job advert indicates the general nature and level of work expected. It is not designed to cover or contain a comprehensive listing of activities or responsibilities required of the incumbent. Incumbent may be asked to perform other duties as required. Additional position specific requirements/responsibilities are contained in approved training curricula.
Visa status re must be eligible to work and live in Ireland as below
Colleague must be legally eligible to live and work in Ireland.
Summary of our Benefits
In addition, to being part the world leading animal health company focused on the needs of those who raise and care for animals we offer a range of benefits such as competitive salary, bonus, 25.5 days holiday per annum plus public holidays, a defined contributory pension plan, private medical insurance for you and your family and empowered flexible working, to name a few. Please note that the benefits outlined are subject to change based on organization decision.