LSC have a great contract opportunity for a Compliance Specialist to join a global Biopharmaceutical company in Carlow. This is a state-of-the-art vaccines and biologics manufacturing facility currently producing many products in various therapeutic areas including: oncology, autoimmunity, pneumonia, and infectious disease.
If you have 3+ years relevant experience in the pharmaceutical industry and/or biotechnology industry and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Acts as compliance point of contact for all SCM/Warehouse/Weigh and Dispense documentation topics.
- Assist in the review of SCM/Warehouse/Weigh and Dispense operational procedures, training materials and procedures for various systems.
- Support documentation in support of investigations, non-conformances, protocols, reports and change controls.
- Assist in the review of data for periodic reviews as required.
- Drive continuous improvement for all aspects of documentation control/ archival.
- Contribute to the achievements of department productivity and quality goals.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- 3-5 years' experience in a quality role (QC/ QA), ideally in a pharmaceutical manufacturing environment.
- Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
- Extensive knowledge of the following systems:
- Change Control
- Deviation Management
- Self-Inspections
- Knowledge of cGMP and GDP required.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Grainne Hodnett at 0214777329 if you have any questions about this opportunity!
