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Administracja biurowa » Pracownik biurowy

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Quality Manager & QP Nr ref.: /JOBS.pl A Senior Quality Assurance Manager opportunity for a multi-national Pharmaceutical company in Cork.The Manager will lead a team of 25 people, with 3 direct reports assuring that products manufactured on site are in accordance with cGMPs as well as corporate and regulatory requirements.Tasks:Team Management; Quality Strategy and Quality OversiteEnsure support for local and global batch-release.Manage QA team through QA team leaders to provide quality and compliance support for the site.Provide quality expertise and oversight of cGMP activities across the site.Ensure support for internal auditing, customer complaints and product reviews.Support departments on matters related to investigations and finished batch releases.Provide support for external FDA inspections.Ensure you have the latest information regarding current regulatory guidance and expectations - proactively ensuring continued compliance.Ensure operations are in compliance with cGMP.Requirements:Qualification in Science or related area (Chemistry, Microbiology or Pharmacy preferred).3 years' experience of biologics.3 years' experience in management of QA.5-7 year's experience within Pharma and QualityExperience hosting regulatory and corporate inspections.Wide ranging technical knowledge and experience within the pharmaceutical industry.A good track record with the FDA, MHRA, EMEA and other regulatory agencies.Skills and Knowledge:Experience of quality systems in a manufacturing environment.Ability to lead technical investigations.Technical knowledge of manufacturing and pharmaceutical plants.Understanding of Quality Management Systems and cGMP for US and EU.Effective facilitator with.Good communication skills at organisation, team and individual levels.If you are interested in making this your next career move, then send us an application. If you are interested to hear more about this opportunity or to see how we may be able to help you further we are looking forward to receiving your application. Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .

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