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Quality Manager/Site GMP Auditor - Ireland  

MSD (company)


Posted on : 09 May 2017

Project Description

Quality Manager/Site GMP Auditor-QUA005787DescriptionMSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company  one that is ready to help create a healthier future for all of us.Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.The Quality Manager/GMP Site Auditor will have the unique opportunity to work across Development, Clinical and Commercial activities for API and Drug Product businesses.Key responsibilities will include:- Lead scheduling and tracking of Quality System Audits and GMP Walk Downs in accordance with approved Audit plans for the MSD Ballydine site- Lead site GMP audits in accordance with approved procedures and applicable standards and regulations- Lead the development and implementation of CAPA following audit program completion- Lead the compilation of quality metrics related to audits for dissemination at Quality Council and Management Review- Recommend and lead implementation of improvements to the Audit and Inspection Management programs based on new regulations, guidance documents, and industry standards- Lead in company and site preparations for support of regulatory and customer inspections- Provide compliance advice to development and commercial product teams- Supports and continually enhances the ongoing site Permanent Inspection Readiness status- Lead training/orientation for new Quality Auditing staff- Ensures that written procedures are followed, and exercises judgment in evaluating quality systems, processes, procedures, and protocols for compliance- Lead effective change management for Audit CAPA delivery- Lead resolution of Supplier Quality issues to assure compliance and a flow of high Quality materials- Reports to the site Quality Director and participates as part of the site Quality Leadership TeamQualifications- Minimum of 7 years Pharmaceutical industry experience within a GMP environment- Extensive knowledge of US and European cGMP guidelines, ICH and other international regulatory requirements- Extensive experience in GMP auditing across multiple Quality Management systems in API and/or Drug Product- Experience in GMP auditing of Computerised System, Supplier Management and Logistics/Warehousing- Experience working directly with regulators in audit situations- Ability to build relationships and influence across disciplines and all levels- Should be highly motivated, flexible, and have excellent organisational and communication skills- Excellent verbal and written communication skills- Ability to prioritise and balance work from multiple projects in parallelOur employees are the key to our company s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.Job: Quality GMP Related Job Title:Quality Manager/Site GMP AuditorPrimary Location: EMEA-Ireland-Munster-TipperaryEmployee Status: RegularTravel: Yes, 5 % of the TimeNumber of Openings: 1Company Trade Name:MSD Job Segment: Audit, Law, CAPA, Manager, Pharmaceutical, Finance, Legal, Management, Science

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Tipperary IE

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