Supplier Quality Specialist

  • Cork
  • Mckesson Europe
PURPOSE OF JOBThe post holder will provide experience and technical support in overseeing contract manufacturing organisations and service providers to ensure McKesson private label products are manufactured and distributed in compliance with internal procedures, FDA and Health Canada regulations. The post holder will participate as a team member managing data which facilitates monitoring supplier activity to ensure compliance, manage risk and minimise supply interruptions across McKesson private labels including Strategic Sourcing Services LLC (SSSL); Northstar Rxllc and McKesson Corporation dba SKY PackagingKEY RESPONSIBILITIESExecution of Quality Management System activities as it applies to Supplier Quality functionsGeneration of departmental metrics and KPIsSurveillance of regulatory authority actions impacting business operationGeneration and distribution of supplier scorecardsTracking and maintenance of quality agreementsProvision of GMP documentation in adherence to quality agreementsDocumentation control arising from Quality Systems action itemsPreparation of annual site risk assessmentsSupport the preparation and periodic review of Supplier Quality SOPs.Partner with Supplier Quality Auditors to enhance departmental audit processes.Support McKesson Enterprise Quality initiativesWork in accordance with I2CARE and ILEAD principlesFoster a culture of learning and engagement, empowering technical judgement and decision making  (The above statements describe the general nature and level of work being performed in this job. Theyare not intended to be an exhaustive list of all duties)REQUIREMENTS:Education/Training:Educated to degree level, minimum B.Sc. (Biological or chemical sciences) or B.Eng, (process and Chemical)Experience:2+ years pharmaceutical manufacturing experience in a regulated facilityBroad knowledge of at least one manufacturing dosage formExperience of laboratory, with considerable expertise in at least one dosage formKnowledge and Skills:Pharmaceutical quality assurance experience preferredAn understanding and knowledge of cGMP, Quality Assurance and regulatory principles in a pharmaceutical manufacturing environmentAn understanding of basic pharmaceutical processes such as a solid dose manufacturing process, aseptic manufacturing processes, packaging process, etc.Experience in risk management tools and techniquesAbility to communicate with suppliers to improve performance; including the ability to influence through effective communication and diplomacyAbility to work independently and make decisions based on judgement and integrityProven analytical skills and ability to transfer findings into well written report formatsAbility to work effectively with others to accomplish goalsDemonstrates and understands customs and beliefs of various groups or culturesExperienced in operating under a Quality Management SystemStrong communication and interpersonal skillsEffective team building abilityA continuous improvement mindsetWork Environment/Physical Demands:Hybrid working model with the ability to work from home and in the general office environment.At McKesson, we care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse employee population and ensure they are the healthiest versions of themselves. As part of Total Rewards, we are proud to offer a competitive compensation package at McKesson. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. Our Base Pay Range for this position€39,800 - €66,300