Operations Lead


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2022-08-11 10:17:361970-01-01Team Horizon
Job TypeContractor
AreaDublinDublinIreland
SectorOperations & Manufacturing
Start Date
AdvertiserHilda Lynn
Telephone+353 98 33013
Job Ref#1002454
Job Views121
Description
Operations Lead– Team Horizon
 
Team Horizon currently has an exciting opening for a Manufacturing Operations Leadto work on our client’s Bio-Pharma site in Dublin. This role may require an ad hoc shift cover.
 
The Operations Lead will serve as primary production process owner responsible for New Product Introduction and Life Cycle Management Projects as well as process improvements projects. They will be the 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.
 
They 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 manufacturing 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 bedoing:
  • 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.
  • 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 licences.
  • Develop, review and update Protocols 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 and develop, review and update Product Quality Risk Assessments.
 
 
What you need to apply:
  • Bachelor’s degree in a science discipline, with knowledge of relevant regulations and regulatory requirements (GMP, EH&S)
  • 3+ years of biopharmaceutical manufacturing experience in Fill Finish or related manufacturing or GMP experience in the pharmaceutical or medical device industry
  • Project Management, organizational skills, and problem-solving 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.
  • Decision Making skills and confidence to challenge others on decisions that impact the manufacturing area.
  • Ensures compliance within regulatory environment
  • Demonstrated ability to work independently and deliver right first-time results under minimal direction.
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