Are you looking to join an award-winning industry leader? We are working with one of Ireland's leading medical device organisations as they continue to grow their Microbiology team. The Project Microbiologist will initially join on a 12-month contract with great scope for extension/permanency in the future. Interested in joining an organisation that prides themselves on their continuous learning and growth opportunities? If you have experience with Bioburden and Endotoxin validation works and experience in a GMP environment then we want to talk to you
Role Responsibilities:
1. Support method transfer, validation and engineering qualification activities
2. Ensure Regulatory compliance in area of responsibility to cGMP's of all medical device regulatory agencies (. FDA and HPRA).
3. Provide key support and technical expertise to the site to ensure people and technical skills are in place to implement new technologies and apply best practice in Microbiological techniques and systems.
4. Take the lead and provide direction in all areas relating to the microbiological validation of the product.
5. Responsible for microbiological systems and associated documentation updates post validation, ensuring they remain current and in compliance to regulatory standards and corporate requirements.
6. Provide functional expertise to other support functions (. regulatory requirements, statistical techniques, sampling principles).
7. Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. Participates in determining goals and objectives for projects.
8. Evaluate quality events ensuring compliance with cGMP and quality standard requirements. Support root cause analysis, product impact assessments and corrective and preventative actions (CAPAs) for quality events. Ensure timely and effective actions are implemented and that CAPA effectiveness checks are conducted.
What the ideal candidate looks like:
9. Third level qualification in Microbiology or related discipline.
10. Ideally 2-5 years' experience within a pharmaceutical GMP environment.
11. Previous working experience with NPI projects with knowledge and application of Microbiology principles associated.
12. Previous bioburden and endotoxin validation experience.
13. Excellent interpersonal and communication skills with good leadership abilities.
14. Strong Decision-making skills and ability to work on one's own initiative.
15. Ability to work with minimum supervision.