Documentation Specialist Upstream Operations
RK23951
Contract 11 months
Dublin



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.



The role will provide key operational support to the Upstream shift teams to ensure right first-time execution/delivery of manufacturing of batches. The Upstream Operations Support Specialist will support routine operations in the areas of safety and GMP compliance and will report to Upstream Operations Support Lead.





Key Responsibilities:

• As an Operations Specialist, you will work with the Integrated Process Team (IPT) to ensure the effective and efficient on-time delivery of batch production in Upstream Operations. This requires the delivery of process excellence and reliability across all areas of the IPT.
• Support Shift Operations team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g., EHS metrics, Production Plan, OEE, compliance and team training, including coordination of daily production activities.
• Manage & track creation & updates to Standard operating Procedures (SOPs) Work Instructions (WI’s) for New Product Introduction
• Ownership of CAPAs
• Support compliant operations through management of materials used in Upstream Operations.
• Data analysis supporting operations in safety quality delivery and cost
• Link to finance department for monthly materials reporting and approvals
• Liaise with stakeholders including Shift Operations, Tech Ops, Quality Assurance
• Collate and analyse downtime tracking data and link to problem solving.
• Provide Communication updates to manufacturing shift teams.
• Co-ordinate and support Audits including preparatory work.
• Coordinating and authoring Quality Notifications and Corrective and Preventive Actions (CAPAs). Ensuring accurate and timely documentation and updates to maintain compliance with quality standards and regulations.
• Co-ordination of Contractors and Visitors to BDS.

• Degree or 3rd level qualification (Science, Engineering).
• Working knowledge of SAP
• Experience with Qualified Document Management systems
• Working knowledge of Upstream processes is highly desirable.
• Knowledge of Lean Six Sigma and Lean methodologies, with an understanding of regulatory requirements.