Process Support Specialist (Biotech)

Process Support Specialist required for a leading Biotech facility, in Carlow, initially an 11 month contract. Responsible for generating and expediting review and approval processes for IPT GMP documentation including but not limited to Quality Notifications, CAPA close out records, IPT Standard Operating Procedures and Standard Work Instructions and change controls. Ensure that objectives are effectively achieved, consistent with requirements to ensure compliance, safety and reliable supply to our customers. ROLE: Support manufacturing activities through documentation generation, equipment and process investigations associated with non-GMP activities and completion of quality notifications. Provide input to the MES development process team on technical aspects of MES functionality and serve as MES SME within IPT Be a document system expert; this will include document review, approval and document system work flow expedition. Format, write, deliver and review necessary documentation i...