Overview
A fantastic and exciting opportunity has arisen for an Upstream Operations Support Specialist. 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. This position will play a pivotal and critical role in the manufacture of biologics-based medicines, including immuno-oncology.
Location: Dublin, County Dublin, Ireland
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 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) and 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.
* Coordinate with 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.
* Coordinate and support audits including preparatory work.
* Coordinate and author Quality Notifications and Corrective and Preventive Actions (CAPAs); ensure accurate and timely documentation and updates to maintain compliance with quality standards and regulations.
* Coordinate of Contractors and Visitors to BDS.
Required Skills
* Working knowledge of SAP.
* Experience with Qualified Document Management systems.
* Self-motivated with excellent organizational skills.
* Ability to interact with multiple stakeholders across numerous departments.
* Ability to work independently and as part of a team.
* Advanced soft skills e.g. MS Word, Excel, PowerPoint to generate metrics and presentations as applicable.
* Excellent communication skills.
Desirable Skills
* Working knowledge of Upstream processes is highly desirable.
* Knowledge of Lean Six Sigma and Lean methodologies, with an understanding of regulatory requirements.
Education
* Degree or 3rd level qualification (Science, Engineering).
Seniority level
* Entry level
Employment type
* Full-time
Job function
* Legal
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