Operations Specialist

Operations Specialist – Team Horizon
 
We are currently recruiting an Operations Specialistwho is keen to develop their career to be part of our client’s team based in Sligo who are a global, research-based biopharmaceutical company that combines the focus and passion of leading-edge biotech with the expertise and capability of an established pharmaceutical leader.
 
Why you should apply:

• Our client has developed a stand-out culture of innovation, inclusion, and development, and consistently features as a great place to work.


• The role is generously compensated and attracts a competitive base salary and highly attractive benefits package and excellent career progression opportunities.

What you will bedoing:

• Applies knowledge, experience, and technical skills to understand Production objectives, to provide support to Production initiatives, to execute systems and procedures efficiently and compliantly, evaluates systems for improvement potential. Use standard practices to ensure inter-group consistency.


• Works, within established systems to improve Good Manufacturing Practices (GMP) compliance.


• ​Schedules work tasks, with limited assistance, to support project/campaign timelines.


• Circulates documents to reviewers with limited assistance, responds to comments and questions.


• Manages document review and approval to meet project timelines.


• ​​​​Exercises judgment within generally defined procedures and practices to determine appropriate action.


• Tracks ongoing problems and gathers information for analysis. Analyze data to develop solutions to general-level problems. Presents a potential solution to management/senior personnel and with assistance creates an implementation plan.


• Assist in the execution of validation activities for the manufacturing equipment. Provide technical assistance related to the manufacturing equipment. Assist in the troubleshooting of the manufacturing equipment.


• Establish requirements and assist in the implementation of changes to the Process Control System.


• Investigates events in production that have quality or compliance impact. Leads or participates in RCPS or FMEA sessions. Documents investigation outcomes.


• Transfers methods into Production instructions. Provides training to ensure successful rollout of new methods.


• Responsible for Inventory maintenance and production tracking. Subject matter expert in SAP for inventory and production.


• Track and report bulk usages and support production in inventory management.


• Track weekly and monthly yield performance and report to Department supervision and Finance.


• Comply with company policies and procedures, Engineering Standards and Specifications, Plant procedures, and regulatory agencies regulations and requirements.

What you need to apply:

• Bachelor’s Degree or equivalent required, preferably in an engineering or related field.


• 5 years’ experience in all aspects of manufacturing/production processes with good writing skills.


• A working knowledge of safety, quality systems, and current Good Manufacturing Practices as applied to equipment and process steps in area of responsibility is required.


• Familiarity with pertinent regulatory filings, tech transfer process and with equipment and facilities validation