What you need to know
You will work as a Qualified Person – Clinical for our client based in Waterford within the healthcare manufacturing sector.
You will be responsible to ensure that all products being released for clinical trial purposes comply with the requirements of the Clinical Trial Authorisation and have been manufactured according to the principles of GMP. You will also manage a team of quality officers.
This is a permanent job
Your new job
Key duties & responsibilities:
- Develop and improve quality systems by identifying areas for improvement and take corrective action to ensure continuous improvement in accordance with Company Continuous Improvement Process.
- Review change proposals and related documentation for compliance with Regulatory approvals and GMP requirements.
- To review and approve batch documentation, investigation reports, change requests, SOP’s and qualification reports.
- To review and release batches according to shipment schedule ensuring all batches are in compliance with regulatory requirements.
- Identify and make recommendations for improvements to the process.
- Ensure that all work carried out is in compliance with the required standards conforming to company, cGMP, cGLPs, SOPs, regulatory regulations and guidelines, H & S and Environmental guidelines.
What are we looking for?
- Proven experience within the Pharmaceutical industry in a QA/QC/Compliance role.
- Qualified Pharmacist OR Graduate of Diploma in Pharmaceutical Manufacturing Technology OR equivalent “Qualified Person” status as defined by E.C. Directive 2001/83; OR pending completion.
- Experience of Product Development, Clinical Programs, Combination Products and Medical Devices will be an advantage.
- Excellent planning and organisational skills.
Apply for this job now by sending your CV to Patricia.
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