LSC have a great contract opportunity for an Associate Quality Assurance Specialist to join a top 10 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.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Provide detailed knowledge of quality systems in place and ensure that root cause is identified and corrective actions as appropriate are completed.
- Provide feedback on re-occurring issues ensuring continuous improvement to systems/processes.
- Ensure changes controls raised are documented, assessed and completed.
- Prepare Annual Process and System Reviews.
- Act as lead/team auditor to support the internal GMP walkdown and scheduled audits.
- Participate in the generation and communication of quality metrics.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Knowledge and demonstrated expertise in Lean / Continuous Improvement.
- Experience and knowledge of GMP Requirements for Electronic /paper free operations.
- Experience in any of the following: High potency/ Spray drying/Laboratory/API/Oral Solid Dose/Project Management desirable.
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!
Contact Grainne Hodnett in LSC on 021 4777 329 to discuss this new role in detail or apply directly via this advert!