R.T. Lane Recruitment are currently recruiting for a QC Specialist to work with a pharmaceutical company based in Tipperary.
This is an 11-month contract with strong potential for extension.
Please note that candidates must hold the correct working visa for Ireland as my client cannot offer visa assistance.
Brief Description:
1. Responsible for the release of incoming goods, products for which production or packaging is outsourced, and products and processes in full compliance with quality procedures, legal guidelines, quality guidelines and market authorization.
2. Responsible for advice on and improvements of quality related issues, in order to ensure an optimal quality of released products and processes.
3. Will understand the quality requirements for the introduction of materials to site, will have the capability to communicate the requirements to suppliers and will use good documentation practices and be capable of implementing these at a local level.
4. Works with moderate work direction and is skilled and knowledgeable to the position.
Roles and Responsibilities:
* Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification.
* Perform and review complaints and deviation investigations, change controls and CAPA’s.
* Compile data for reports and presentations, providing data interpretation and present conclusions.
* Completes audits to ensure compliance to SOPs, GMPs and applicable regulations.
* Support product recalls and stock recoveries as appropriate.
* Engage with multi-disciplinary teams to help resolve comments and issues that arise during audit and review which requires the successful candidate to have excellent communication skills and be able to work as part of a team as well as an individual.
* Identify compliance gaps and make recommendations for continuous improvement.
* Carries out all assignments to the standards of compliance, efficiency, innovation, accuracy, and safety in accordance with Company and regulatory requirements.
* Keeps up to date with cGMP requirements on a worldwide basis.
* Additional activities as assigned by the manager/supervisor.
Skills:
* A degree in a Science or Engineering discipline.
* Must have pharmaceutical experience – candidates without this will not be considered.
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