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Avishek Singh
Life Science

00353872827991
[email protected]
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Details

Operations Lead


Reference:AS33864 Location: Dublin
Qualification:DegreeExperience:3-4 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Manufacturing and Technology Manager, Manufacturing Engineer, Operational Excellence Lead, Production Engineer

Operations Lead

12 Months

AS33864

We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Ideally the person will have biopharmaceutical manufacturing experience in Fill Finish or related manufacturing or GMP experience in the pharmaceutical or medical device industry. This person needs to have experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.

Duties:

  • Function as the site interface between the Product Delivery Teams (PDT’s), and site Manufacturing operations.
  • Develop, review, and approve Generic Master Batch Records and Parameter Value Lists across Formulation, Filling and Inspection.
  • Perform Job Hazard Assessments and Change Control Assessments to determine impact to Manufacturing.
  • Evaluate, plan, and implement solutions for process improvement opportunities both current and project related.
  • Support scheduling and execution of Characterisation, Engineering and PPQ runs, 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.
  • Consult 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.
  • Documentation and approval of protocol deviations for manufacturing activities.
  • Consult with Process Development, Direct manufacturing, Equipment, and System Owners regarding process changes in an effective and timely manner.
  • Own and lead change controls as required by the Manufacturing support team.
  • Develop, review and update Product Quality Risk Assessments.

Education and Experience:
  • Bachelor’s degree in a science discipline.
  • 3+ years of biopharmaceutical manufacturing experience in Fill Finish or related manufacturing or GMP experience in the pharmaceutical or medical device industry.
  • Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
If interested in this posting please feel free to contact Avishek Singh at [email protected] or 0872827991 for further information.