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