Operations Lead
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| Job Type | Contractor |
| Area | Dublin, Ireland |
| Sector | Operations & Manufacturing |
| Start Date | |
| Advertiser | Hilda Lynn |
| Job Ref | #1002032 |
| Job Views | 187 |
- Description
- We are seeking applications for a capable and motivated candidate for our client, who is a leading biopharmaceutical company based in Dublin. You will serve as primary production process owner responsible for New Product Introduction and Life Cycle Management Projects and process improvements projects. You will be operations point of contact for coordination of the manufacturing effort and will be responsible for driving process efficiencies as part of the project for operations. You will apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to ensure streamlined manufacturing operations are enabled in both vial and syringe facilities.
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 in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.
What you will be doing:
Function as the site interface between the Product Delivery Teams (PDT’s), and Manufacturing operations.
Develop, review and approve generic batch records and parameter value lists across Formulation, Filling and Inspection
Develop, review and update Production, Engineering, Operating Procedures & training materials
Assist in providing training on scientific or technical aspects of the process/project
Evaluate, plan, and implement solutions for process improvement opportunities
Support scheduling and execution of characterisation, engineering and PPQ runs including ensuring all necessary pre-requisites are included on the schedule and assess process performance by observation of floor operations and review of performance data
Provide troubleshooting support throughout the project and on the floor during execution of activities
Hold people to account for delivery and behaviours within Product team
Perform Job Hazard Assessments and Change Control Assessments to determine impact to Manufacturing
Partner with Learning & Performance to define training strategy’s for NPI’s and complex projects
Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current SOP’s, batch documentation and licenses
Develop, review and update Protocols for manufacturing activities
Documentation and approval of protocol deviations for manufacturing activities
Liaise with Process Development regarding process changes in an effective and timely manner
Own and lead change controls as required by the NPI Project Team
Review and approve bills of materials
Develop, review and update Product Quality Risk Assessments
Ideally what you need to apply:
Previous experience in pharma industry will really benefit you in this role especially experience from the Biopharma manufacturing industry.
Project Management and organizational skills, including ability to follow assignments through to completion
Problem solving skills: Gathers data from key stakeholders, analyses and interprets information to develop solutions to technical problems of moderate complexity
Negotiation and Influence skills
Take initiative to identify and drive improvements
Excellent verbal and written communication skills: Strong Technical writing skills for GMP documentation (e.g., investigations, procedures, change controls) and good Presentation skills
Escalate issues professionally and in a timely manner
Decision Making skills and confidence to challenge others on decisions that impact the manufacturing area
Teamwork and Coaching others
Ensures compliance within regulatory environment
Demonstrated ability to work independently and deliver right first-time results under minimal direction
Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products would also be beneficial.