Operations Specialist
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| Job Type | Permanent |
| Area | Sligo, Ireland |
| Sector | Operations & Manufacturing |
| Start Date | |
| Advertiser | Mary King |
| Job Ref | 2580 |
| Job Views | 613 |
- Description
- Team Horizon is seeking an Operations Specialist for our client based in Sligo who are 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:
· This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
· There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
· Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.
What you will be doing:
· 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. Support production in inventory management. Interface with Planning to create and manage production process order numbers and batch numbers. Initiate and track blanket purchase orders for goods and services to support production. Track weekly and monthly yield performance and report to Department supervision and Finance.
· Frequently interacts with functional peer groups. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects, schedules, etc.
· Comply with 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.
· At least 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. Proficiency with tech transfer process and familiarity with equipment and facilities validation
· Must be flexible to handle multiple tasks including ability to handle pressure in a professional manner.
· Effectively work in a team environment.
· Maintain high level of energy and professionalism on the job.
Build effective working relationships with customers, co-workers, cross-functioned groups, and management.
