Quality Assurance Laboratory Leader

2 weeks ago

Co Meath, Ireland beBeePharmaceutical Full time €70,000 - €95,000

Lab Quality Assurance Manager

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We are seeking a highly skilled Lab Quality Assurance Manager to lead our In-Process Control (IPC) laboratory team. This is an excellent opportunity for someone who wants to take their career to the next level and make a real impact in the pharmaceutical industry.

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The successful candidate will be responsible for overseeing the technical transfer of IPC analytical methods and testing of Active Pharmaceutical Ingredients, intermediates and cleaning samples. They will also be responsible for ensuring compliance with regulatory requirements and company policies while driving continuous improvement initiatives.

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This role requires a strong leader who can motivate and guide a team to achieve high-quality results. The ideal candidate will have a deep understanding of current regulatory requirements for IPC or QC, including analytical testing, data integrity, and cGMP laboratory equipment validation.

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Key Responsibilities:

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  • Lead the planning and execution of analytical method transfers for IPC testing, ensuring adherence to project timelines and objectives.">
  • Serve as the primary point of contact for all IPC technical transfer activities, liaising between internal analytical teams, manufacturing sites, and external partners.">
  • Coordinate the development and validation of IPC analytical methods, including protocol design, execution, and documentation.">
  • Conduct risk assessments and troubleshooting activities to address IPC technical challenges and ensure the successful implementation of analytical methods.">
  • Generate and review technical documents, including IPC transfer protocols, reports, and standard operating procedures (SOPs), to support IPC method transfer activities.">
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Requirements:

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  • B.A. / B.Sc. or equivalent in Biological Sciences, Chemistry or other biotechnical science or equivalent experience in a regulated industry.">
  • Minimum of 10 years of laboratory experience in a GMP laboratory environment.">
  • 5 years of analytical instrument validation/qualification experience preferable.">
  • Proven leadership of laboratory staff and experience in a GMP laboratory.">
  • Proven ability to work in a matrixed organisation.">
  • In-depth understanding of current regulatory requirements for IPC or QC, including analytical testing, data integrity, and cGMP laboratory equipment validation.">
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