As a key player in our medical device organization, you will be instrumental in driving growth and success within our Microbiology team. This exciting 12-month contract offers great scope for extension or permanency in the future.
About the Role
* Support the transfer of methods, validation, and engineering qualification activities to ensure seamless product implementation.
* Maintain regulatory compliance in your area of responsibility, adhering to cGMP standards set by medical device regulatory agencies.
* Provide technical expertise and support to ensure site personnel have the necessary skills to implement new technologies and apply best microbiological practices.
* Take the lead in validating products' microbiological aspects, ensuring they meet regulatory requirements.
* Oversee microbiological systems and associated documentation, ensuring they remain current and compliant with corporate and regulatory standards.
* Promote functional expertise among other support functions, covering regulatory requirements, statistical techniques, sampling principles, and quality events.
Your Qualifications
* A third-level qualification in microbiology or a related field is essential.
* Ideal candidates possess 2-5 years of experience in a pharmaceutical GMP environment.
* Previous experience with NPI projects and knowledge of microbiology principles are highly desirable.
* Bioburden and endotoxin validation experience are also valuable assets.
* You must have excellent interpersonal and communication skills, with good leadership abilities and strong decision-making skills.
* The ability to work independently with minimal supervision is essential.
Benefits
This role offers an opportunity to join a leading medical device organization that values continuous learning and growth opportunities.