LSC have a great contract opportunity for a Quality Assurance 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 Bachelor's Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline with a Minimum Experience of 3-5 years and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
The QA Specialist (NPI / DS / Materials) will participate as a core member of the Technical Transfer Team that manages Vaccine and Biological product development and manufacture, along with day to day QA activities, including:
- Ensuring that the process for the introduction of biologics/vaccines is in compliance with cGMP and the associated regulatory requirements.
- Reviewing and approving documentation to support corporate compliance/regulatory expectations for manufacturing.
- QA oversight on the receipt and release of Drug Substance to site.
- Provide quality oversight and direction for the introduction of new products, drug substance and materials onto site covering the end-to-end strategy.
- Quality point of contact at both a site level and for all external inputs (Transfer Site QA/QC/ Regulatory), including co-ordination of/attendance at Quality working group meetings.
- Facilitate compliance direction for the site by assisting in the adherence to divisional policies and guidelines as well as regulatory requirements. Assist in the proactive evaluation of site compliance against emerging regulatory trends. Identify and facilitate major compliance initiatives to improve compliance status and overall operational efficiency of the site.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- 3-5 years experience in a quality role, ideally in a pharmaceutical manufacturing environments
- Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
- Knowledge of cGMP and GDP preferred
- Report, standards, policy writing skills required
- Equipment and process validation
- Sterile filling processes and equipment
- Proficiency in Microsoft Office and job related computer applications required
- Lean Six Sigma Methodology experience desired
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 Gráinne Hodnett at 0214777329 if you have any more questions about this opportunity!