LSC have a great contract opportunity for a QA Specialist to join a Dublin based Biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that can help patients overcome serious diseases and improve their quality of life.
If you have 3+ years industrial experience and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Compilation and review of batch release dossiers for Qualified Person certification of IMP to clinical trials.
- Updates and maintains the site Manufacturing and Importation Authorisation (MIA) in accordance with regulatory requirements and maintains the Site Master File.
- Generates and maintains Product Specification Files (PSF) for IMP.
- Provides QA support and oversight of packaging and labeling operations for IMP.
- Support the generation and ongoing maintenance of Quality Agreements.
- Provides Quality Assurance support in the Use Date Extension process.
- Provides Quality Assurance oversight and support (GMP/GDP guidance and training) for CSO Logistics (EMEA and Asia)
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- A degree in science, engineering or related discipline is essential along with 3 years' experience in a role within the biopharmaceutical/pharmaceutical industry
- Demonstrated strong knowledge of ICH/GMP, data integrity, regulatory guidelines/directives, clinical supply chain processes and principles of Quality Assurance
- Required to work on his/her own initiative in addition to working as part of a team. The candidate must be able to work across a team matrix in order to meet accelerated timelines.
Applicants interested in our contracting opportunities within the pharmaceutical sector in Ireland are required to have a Stamp 1G or a Stamp 4 visa. Please understand that we are unable to provide visa sponsorship. Thank you.
Apply via this advert or contact Sarina Abdulha on 021 4777 329 if you have any more questions about this opportunity!
