McKesson Quality Auditor in Munster, Ireland
McKesson is in the business of better health and we touch the lives of patients in virtually every aspect of healthcare. We partner with payors, hospitals, physician offices, pharmacies, pharmaceutical companies and others across the spectrum of care to build healthier organizations that deliver better care to patients in every setting. We believe in the importance of strong, vital organizations because we know that patients can only be healthy when our system is healthy.
Every single McKesson employee contributes to our mission—by joining McKesson you act as a catalyst in a chain of events that helps millions of people all over the globe. Talented, compassionate people are the future of our company—and of healthcare. At McKesson, you’ll collaborate on the products and solutions that help us carry out our mission to improve lives and advance healthcare. Working here is your opportunity to shape an industry that’s vital to us all.
We understand the importance of a system that works together. Your expertise, drive and passion can help us improve everything we touch, from providers to payors to pharmacies. Join our team of leaders to begin a rewarding career.
Wherever you contribute here at McKesson, you will have the ability to make a real impact in the lives of others.
NorthStar Rx LLC ("NorthStar", a business of McKesson) supplies high quality generic pharmaceuticals. NorthStar products are manufactured at established facilities that are registered with the U.S. Food and Drug Administration (FDA). We manufacture generic drugs in an efficient and cost-effective manner to generate increased savings for you.
Job Title: Quality Auditor
PURPOSE OF JOB
As a member of the auditing team the post holder will be responsible for assisting the Auditor Manager in ensuring that licensed pharmaceutical products are manufactured, tested and released in compliance with cGMP, US FDA and other applicable regulations. The key function of this role is to minimise the risk to NorthStar by ensuring a high level of compliance is being adhered to for outsourced work. The post holder will be the lead for auditing and associated activities in our contract manufacturer sites in India and other territories on a regular basis; this will require travel to these regions approximately 40% of time.
Lead and conduct quality inspections of outsourced manufacturing facilities, including, but not limited to, solid dose finished product manufacturing facilities and sterile finished product manufacturing facilities to ensure compliance with cGMP and US FDA regulations.
Lead and conduct responsible sourcing inspections of outsourced manufacturing facilities as per company guidelines.
Lead and conduct quality inspections of other third party service providers such as packaging sites, API manufacturing facilities and contract laboratories.
Compile inspection reportsto include findings, corrections and process improvements.
Track corrective actions and planned action agreements from inspections to closure.
Participate in continuous evaluation and improvement of all quality aspects at manufacturing sites with particular emphasis on process systems and QMS.
Carry out NorthStar Healthcare business and compliance due diligence exercises
Assist in ensuring compliance policies are managed correctly and efficiently and provide recommendations and direction to relevant parties as necessary
Keep the Management team and colleagues updated on issues and actions which impact the business
Participate in regular team and group meetings
Be flexible within the Quality function to meet the needs of the growing business; using technical expertise, skills, knowledge and experience as required.
(The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties.)
Educated to degree level or high, minimum B.Sc. (biological or chemical sciences) or B. Eng, (process and chemical).
6 years pharmaceutical manufacturing experience in a similar type role within a progressive multinational organization. Broad knowledge of at least one dosage form e.g. sterile’s/injectables or solid dose manufacturing is important. Experience of laboratory, with considerable expertise in at least one pharmaceutical field.
Provenexternal auditing experience
Proveninternal auditing experience
Solid understandingand knowledge of cGMP, Quality Assurance and regulatory principles in a pharmaceutical manufacturing environment including ICH guidelines and CFR part210 / 211 regulations, 21 CFR Part 11 regulations.
Solid understanding of Quality Management Systems
Solid understanding of basic pharmaceutical processessuch as a solid dose manufacturing process, aseptic manufacturing processes, packagingprocess, etc.
Responsiblesourcing experience while an asset is not essential as training will be provided
Excellent communication skills with ability tocommunicate at all levels within the organization
Demonstrateability to lead customers to improve performance or effectiveness; includingthe ability to influence through effective communication and diplomacy
Ability to compile and made presentations at externalsites to senior management level.
Ability to work independently and make decisions basedon judgement and integrity
Proven analytical skills and ability to transferfindings into well written report formats
Experience / training in problem solving and process improvementmethodologies
Ability to work effectively independently and withothers to accomplish goals in a challenging environment
Excellent organisational and time management skills
Demonstratesand has an understanding of customs and beliefs of various groups orcultures.Understands how thesedifferences affect performance and communication
Quality Management systems e.g track wisemaster control SAP
General office environment with onsite visits to manufacturing facilities and laboratories requiring travel to India and other foreign locations approximately 40% of the time.
Job: Distribution Operations
Organization: McKesson Corporate
Title: Quality Auditor
Requisition ID: 17005161