Job Title: Senior Microbiology Specialist
We are seeking a highly skilled and experienced Senior Microbiology Specialist to join our team. In this role, you will play a key part in supporting the growth of our microbiology department.
The ideal candidate will have:
* A strong understanding of microbiological principles and practices
* Excellent communication and interpersonal skills
* Able to work effectively in a team environment
* Strong problem-solving and analytical skills
Key Responsibilities:
* Support method transfer, validation and engineering qualification activities
* Ensure Regulatory compliance in area of responsibility to cGMP's of all medical device regulatory agencies (e.g. FDA and HPRA)
* 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
* Take the lead and provide direction in all areas relating to the microbiological validation of the product
* Responsible for microbiological systems and associated documentation updates post validation, ensuring they remain current and in compliance to regulatory standards and corporate requirements
* Provide functional expertise to other support functions (e.g. regulatory requirements, statistical techniques, sampling principles)
* Establishes and cultivates a wide range of business relationships to facilitate completion of assignments
* Participates in determining goals and objectives for projects
* 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
Requirements:
* A third-level qualification in Microbiology or related discipline
* Ideally 2-5 years' experience within a pharmaceutical GMP environment
* Previous working experience with NPI projects with knowledge and application of Microbiology principles associated
* Previous bioburden and endotoxin validation experience
This is an exciting opportunity for a motivated and experienced professional to take on a challenging role and contribute to the success of our organisation.