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Laboratory Manger Combination Products

Reference:SCAHEC-168104
Location: Dublin
Qualification:Degree
Experience:5-7 Years
Job Type:Permanent
Salary:Not Disclosed
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Laboratory Manager Combination Products
Our Dublin based client are currently recruiting for a Laboratory Manager to join their device development team. This is permanent opportunity with an exciting group where you will gain exposure to a number of very interesting projects.

Responsibilites

  • Oversight of Laboratory operations including Sample Management, Testing Schedule, Equipment Installation and Qualification, Computer System Validation (CSV), Preventative Maintenance and Calibration Schedules and ensuring compliance with ISO 13485 and the Quality Management System.
  • Responsible for scheduling testing in line with project plans and agreed timelines.
  • Lead audit readiness for laboratory inspections by supporting laboratory related queries, tours and interactions with auditors as required.
  • Responsible for leading Quality and Technical investigations with cross functional teams and ensuring investigations are closed out on time.
  • Responsible for compilation and review/approval of SOPs, test protocols, reports and specifications in line with global regulatory requirements, guidance’s and the latest regulatory and industry thinking
  • Review and interpretation of analytical data in line with study and protocol objectives. Trending and statistical analysis of analytical data and compilation of technical reports for product development, stability and process validation studies
  • Responsible for robust method development and validation in line with ICH , USP and other relevant regulatory requirements
  • Perform analytical technology transfer to commercial Quality Control Laboratory by participating in knowledge share, training and laboratory set up.
  • Vendor management. Identify CROs capable of performing device testing to meet EU, US and ROW regulatory requirements. Work with the Quality and legal groups to get CROs approved for testing. Establish relationship and manage timelines and contracts to support project requirements.
  • Well-developed communication skills to lead or facilitate effective discussions. Able to communicate technical and/or project information to key stakeholders.
  • Responsible for ensuring that all relevant activities are compliant to the EHS policies and procedures and that all relevant training is completed.


Requirements

  • Degree in Science and/or Engineering with at least 5 years’ experience of late stage R&D or Technical Support for drug product ideally having worked on drug product in a delivery device such as a pen injector, pre-filled syringe or inhaler
  • Experience of and participating in an FDA or HPRA audit
  • Experience of generating and interpreting analytical data to support regulatory submissions
  • Experience of laboratory equipment qualification
  • Strong Technical writing skills
  • A working knowledge of ISO 13485 & FDA 21 CFR Part 820 Design Control requirements would be an advantage.
  • Highly driven and motivated person who can work as part of a flexible, dynamic team.
  • An understanding of the requirement to meet project and team orientated goals and the ability to create win-win relationships with other functions to meet these goals
  • Proficiency in speaking, comprehending, reading and writing English is required









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