* The Specialist contributes and guides completion of milestones associated with specific projects and supports ongoing quality assurance responsibilities in support of: Manufacturing oversight and new product introduction including Change Control, Deviations, CAPAs and Supplier Management.
* Performs all responsibilities in accordance with company policies, procedures, and federal regulations.
* The incumbent will be responsible for supporting drug product manufacturing and assessing the compliance of this program against best industry practice and current regulatory expectations.
* 2+ years QA experience in a HPRA/FDA/EU & GDP regulated environment
* Degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering)
* Knowledge of GDP and global regulatory requirements
* Sound awareness and understanding of pharmaceutical and biotech business, especially with regards to quality and regulatory requirements
* Strong Interpersonal skills and ability to interact constructively with all functions in a matrix organization environment
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
Fastnet - The Talent Group
'Not Just Placers.........Partners'
The Life Science Specialists