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Qualified Person (QP) Nr ref.: /JOBS.pl Qualified Person (QP) - Dublin, permanent - up to €90,000p/aOptimus Life Sciences is working with a global pharmaceutical client to find a Qualified Person to support Clinical Trials. Reporting directly to the Head of Quality, the incumbent will be focusing on the batch-release of Active Pharmaceutical Ingredients (APIs) and update the Quality Management Systems in order to resolve change control, and complaints or investigations. Tasks: * To provide independent QA/QP oversight of all operations * To implement QP batch-release of product(s) to market as required, to include commercial and clinical trials products. * To ensure that appropriate quality standards and systems are in place, and applied across the site operations in accordance with regulatory and global requirements. * Provide you with easy to follow release procedures which provide a consistent, secure, structured approach that has been repeatedly reviewed during MHRA inspections * Ensure you have the latest information regarding current regulatory guidance and expectations - proactively ensuring continued compliance * Global auditing of third party manufacturing, testing, packaging and labelling facilities as required in support of QP declarations for import into the EURequirements: * A QP is required to have qualifications in Chemistry, Pharmacy or Microbiology * Wide ranging technical knowledge and experience within the pharmaceutical industry. * As required by the Clinical Trial Directive 2001/20/EC and Annex 13 to the European GMP Guide, all Investigational Medicinal Products (IMPs) must be certified by a Qualified Person (QP) prior to release for use in a Clinical Trial. * A proactive approach which builds Quality & Compliance into processes. * Experience in cementing teams, and delivering outstanding effectiveness from those teams. * A good track record with the FDA, MHRA, EMEA or other regulatory agencies.If you are interested, please get in touch with:Rob Chaplin, Optimus Life Sciences, (0) . Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .

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