Our mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow.
We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products in our Allergan Aesthetics portfolio.
Job Description:
Aseptic Manufacturing Specialist will be responsible for defining and updating procedures for site in relation to gowning, aseptic behaviours and contamination control strategy.
This person will be an SME in sterility assurance, microbiological, environmental monitoring and contamination control topics and has the opportunity to have a positive impact on our growing site.
Key Responsibilities:
* Implement an effective and robust training and requalification program for isolator activities, Grade C and Grade D gowning and aseptic behaviours on site.
* Provide governance and support for sanitisation programs on site.
* Support the facilities sterility assurance program and microbiological support activities to ensure facility design, equipment and filling process met aseptic requirements from design to end user.
Requirements:
A thorough knowledge of aseptic and sterile processes together with experience within a GMP environment and knowledge of current EU/FDA/ICH/HPRA and Annex 1 guidelines.
3-5 years' experience in microbiology is a requirement & working in a sterile/aseptic/pharma environment is a distinct advantage.
Experience in supporting regulatory inspections is an advantage.
Qualifications:
Bachelor Degree qualification in biology or microbiology
Additional Information:
AbbVie is an equal opportunity employer committed to operating with integrity, driving innovation, transforming lives and serving our community.