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Qualified Person (QP) Carlow Ireland,  


Posted on : 03 May 2017

Project Description

Qualified Person (QP)-QUA004690DescriptionMSD 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.This position reports to the Quality Lead and will be part of the Quality Organisation at Carlow.Job Purpose- Responsible for ensuring that the process for the manufacture of drug product at MSD Ireland (Carlow) is in compliance with cGMP and the associated regulatory requirements.Principal Accountabilities- Responsible for reviewing and approving GMP documentation to support corporate compliance/regulatory expectations for manufacturing operations.- Provision of advice on all aspects of Regulatory GMP practices and systems.- Design, develop and deliver training courses for QA/QP function on aspects on aseptic processes for finished pharmaceuticals.- Actively participate in Plant/Quality committees and works with other site functional groups, such as the Production and Maintenance to help set direction for GMP initiatives.- Facilitate compliance direction for the site by assisting in the adherence to divisional policies and guidelines as well as regulatory requirements. Assist in the proactive evaluation of site compliance against emerging regulatory trends.- Identify and facilitate major compliance initiatives to improve compliance status and overall operational efficiency of the site.Support the introduction of new products onto site in relation to Quality oversight, covering the end to end product release strategy.QualificationsTypical Minimum Education:- 5+ years  experience of working as a releasing QP IN Drug Substance and/or aspectic filled pharmaceuticals- Knowledge of EU/US quality related pharmaceutical regulationsTypical Minimum Experience:- Experience of conducting quality based investigations and root cause analysis.- Provide quality input to ensure batch impact is properly assessed.- Work with cross functional team including technical SME s to ensure that appropriate corrective and preventative measures are assigned.Qualified Person requirements as defined in EC directive 2001/83/EC and 2001/20/EC.Our 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: Qual Assurance & Ops Generic Job Title:Qualified Person (QP)Primary Location: EMEA-Ireland-Leinster-CarlowEmployee Status: RegularTravel: Yes, 5 % of the TimeNumber of Openings: 1External Job Board Posting: Ireland - IrishJobs.ieCompany Trade Name:MSD Job Segment: Law, Quality Assurance, Pharmaceutical, Compliance, Animal Health, Legal, Technology, Science, Veterinary

Locations

Carlow IE

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