LSC have a great contract opportunity for an Associate Quality Specialist to join a global Biopharmaceutical company in Cork.
The facility specializes in the fermentation, purification, and sterile filling of biotech products, as well as supporting product development and clinical trials. ABOUT THE PROJECT - KEY RESPONSIBILITIES: Provides to the site expertise in Quality Systems and/or Operational Quality, including the following i.e.
Quality Notifications/Investigations/ Change Management; environment monitoring programs; sterility assurance/low bioburden manufacturing; etc.Uses knowledge to improve Quality Systems and/or Operational Quality; solve complex problems, provide continuous improvement and execute tasks.Required to be proficient in Quality approval and oversight for Commissioning and Qualification activities (IQ/OQ/PQ)Provides compliance contribution to project teams and leads small projects.Coaches and guides colleagues within the site.Participation in inspections of Site by Divisional / Regulatory Bodies / third parties together with follow up actions where applicable.Deviation Management & Change Control approval.Champion the highest Quality and Compliance standards for the site.ABOUT YOU - ARE YOUR SKILLS A MATCH? Degree or 3rd level qualification (Science, Quality).Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation.5 years' experience in the pharmaceutical industry or a similar operating environment which includes experience in a Quality function.Quality Assurance SME knowledge, from both operational and educational experience, is required.Advanced PC skills such as Excel, Word, PowerPoint.Stakeholder management of multiple decision makers, auditors, cross functional teams by demonstrating the ability to maintain and strengthen trust relationships with people on all levels.Note: Are you currently eligible to work in Ireland?
As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply! Apply via this advert or contact Grainne Hodnett @ 0214777329 if you have any more questions about this opportunity!
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