Quality Control Manager

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What you need to know

Do you want to work for a leading innovative health manufacturing Company in the midlands? Continue to read if so…

You will work as a Quality Control Manager for our client in Co. Offaly. 

As the Quality Control Manager, you will be responsible for the coordination of in-process and final product testing and release.   You will lead and develop a team in the development, transfer and validation of  bioanalytical methods and product development. This is a cross functional role in that it will also support production and development.

The company is a leading organisation in their field.

This is a permanent job.

Your new job

Key duties & responsibilities:

  • Build, lead and develop a team with expertise in development, validation & transfer of analytical test methods used for the testing and characterisation of biopharmaceuticals and associated raw materials
  • Develop, optimise and validate all required analytical test methods, either in-house or in collaboration with external service providers
  • Manage technical transfer of analytical test methods from external partners to the manufacturing facility
  • Coordinate in-process and final product testing & certification of recombinant antibodies.
  • Oversee the initiation, coordination and management of stability studies from development through to commercialisation
  • Establish test method and validation protocols, SOPs, specifications and other quality system documentation to allow the execution of the analysis in a GMP environment. This will include trending data, setting specifications, monitoring Out of Specifications and taking a lead role in laboratory investigations
  • Liaise with the manufacturing team to support and provide in-process & release testing of the ongoing manufacturing campaigns within required timeframes
  • Work closely with manufacturing/process development to support the development of a robust manufacturing process and transfer to the GMP facility as required
  • Assume an active role in audit preparation ensuring the QC function is audit ready
  • Work closely with specialist contract testing service providers to ensure execution of all deliverables
  • Oversee microbiological & environmental monitoring testing programs to support GMP manufacture
  • Oversee outsourced raw material testing requirements to support GMP manufacture.
  • Support equipment qualification projects and work with vendors to ensure execution of all deliverables, including equipment qualification and validation activities
  • Provide technical reports on completion of development and validation tasks
  • Develop good project management & planning skills to enable coordination and management of various project activities
  • Participate in Internal Quality Audits and Quality and Safety regulatory Audits.

 

What are we looking for?

  • PHD, MSC in Chemical/Biochemical Engineering or related Biological Sciences
  • 5 years of industrial experience in development/validation of bioanalytical test methods.
  • Qualification/Validation of test methods
  • Experience in leading a team and managing a laboratory.
  • Knowledge of regulatory guidelines to analytical development and validation.
  • Knowledge of testing, specification setting and stability study.
  • Experience in test methods used in the analysis of proteins.
  • Management of CMO / CRO activities.
  • Excellent project management capability.

Apply for this job now or get in touch with Breda 

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Recruitment Consultant: Breda Dooley

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