LSC have a great contract opportunity for a Quality Specialist to join a top Pharmaceutical company based in Tipperary. The site supports the complete pharmaceutical small molecule process for Phase III clinical to product release and market support. On site processes include API manufacture, formulation, OSD tableting, packaging and global logistics & distribution. The facility takes in raw chemicals and ships finished medicines to end users. This site has grown from an API site to a strategically important campus that supports critical stages of the company's drug lifecycle.
If you have a degree in Science or Quality and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Sub System Ownership
- Quality SME for Process, Cleaning, Water, Equipment
- Equipment Qualification Validation Committee (EQVC).
- SAP Quality Process Steward
- Quality SME for Change Control.
- Laboratory QA oversight
- Stability oversight
- Microbiology Point of Contact.
- Quality Agreement System Management
- Creation, review and approval of Site Quality documentation
- Quality Council
- Supplier Change Evaluations - Quality Role
- Filing & Licence maintenance and Regulatory Requests follow ups
- QA Regulatory Data
- Returned Goods
- Audit program
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Minimum of Degree or post-graduate qualification in Science, Pharmacy or Engineering field
- Strong Communication skills both written and oral including persuading others
- Pro-active approach
- Planning and scheduling
- Technical report writing
- Time management
- Analytical Problem-solving skills applied to issue identification and resolution
- Laboratory testing and documentation
- Validation principles and guidelines
- System Development Life Cycle
Please note that for our contracting opportunities in the pharmaceutical sector in Ireland, candidates must possess either a Stamp 1G or a Stamp 4 visa. We regret that we are unable to provide visa sponsorship at this time. Thank you for your understanding.
Apply via this advert or contact Gráinne Hodnett on 021 4777 329 if you have any more questions about this opportunity!
