Production Assistant - Small Molecule

Role Overview

The Production Assistant within the Production Business Unit plays a crucial role in supporting the management of production batch records and coordinating production activities on-site, ensuring smooth and compliant operations in small molecule manufacturing.

Primary Responsibilities

• Serve as the main contact for Nexus support during 8-hour shifts, providing frontline assistance to end-users with operational system issues.
• Continuously monitor the PI sheet and maintain virtual production areas.
• Track and account for non-routine material usage accurately.
• Review and update manufacturing, cleaning, and set-up tickets on Regulus, ensuring revisions are current.
• Compare manufacturing tickets with goods movement reports to identify discrepancies, investigate, escalate as needed, and uphold complete data accuracy.
• Assist operators in resolving scanning challenges, including over, under, and key component discrepancies.
• Participate actively in Business Continuity Planning (BCP) activities to maintain production resilience.
• Provide urgent support in tanker unloading and solvent recovery areas during emergencies.
• Conduct In-Process Intermediate Testing (IIT), Final Intermediate Testing (FIT), and Stability testing as required.
• Oversee cleaning ticket review on assigned rigs and report on task completion during execution phases.
• Facilitate production scheduling and coordinate tasks to ensure timely fulfillment of production plans.

Documentation and Compliance

• Implement a uniform documentation process across all production rigs.
• Manage the release of GMP tickets for all rigs, ensuring Good Documentation Practices (GDP), adherence to Good Documentation Practices (GDP), appropriate attachments, Certified Product Profile (CPP) reviews, and completeness.
• Monitor and track documentation errors across shifts and teams, identifying trends and recurring issues.
• Collaborate with Production Operators, Chemists, Assistants, and Quality Integration Teams to resolve concerns and improve processes.
• Support the deployment of On-Site Standardized Chemical Execution (OSSCE) in the assigned production area.
• Initiate Level 1 Quality Deviations for all rigs and escalate incidents as necessary.
• Manage the ticket room workflow and ensure efficient handling of completed production tickets.
• Administer routing of new and revised procedures, batch records, and compliance documents via the document management system.

Requirements and Qualifications

• Genuine interest and understanding of production operations and business processes.
• Proficiency in IT, especially across Microsoft Office applications.
• Strong interpersonal and communication capabilities paired with a helpful attitude.
• Capable of addressing unforeseen problems with solution-oriented thinking.
• Experience and strict adherence to Good Documentation Practices (GDP) and procedure compliance.
• Self-driven and able to operate independently without close supervision.
• Familiarity with SAP or equivalent ERP systems is advantageous.
• Willingness to respond to unplanned call-ins for handling plant emergencies and critical business scenarios.

Educational Criteria

The role requires a Leaving Certificate or equivalent educational qualification and/or relevant experience in a similar capacity.