LSC have a great contract opportunity for a Senior quality Specialist to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
If you have 7 years of pharmaceutical experience and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities for Aseptic products,.
- Quality review and approval of Process Development and Validation documentation
- Technical transfer documents
- Validation Protocols, executed validation documents and reports
- Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- University degree. Science or engineering related discipline preferred.
- Understanding of principles of Validation and New Product Introduction
- Experience in aseptic manufacturing
- Relevant experience (7yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Manufacturing)
- Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
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 on 021 4777329 if you have any more questions about this opportunity!
