Quality Specialist - Cork

Pe Global

Cork

PE Global are currently recruiting for an Associate Quality Specialist for a client site in Cork: Purpose of Role: This Associate Quality Specialist will provide quality oversight, support and knowledge to activities relating to Quality Systems across the site and in meeting the Manufacturing Division. Priorities of: Compliance, Supply, Strategy and Profit Plan. Activities Within Role: This role requires the delivery of a robust Quality Management System to support a flexible, collaborative, multi-skilled teamwork environment. The team working style is one of collaboration, coaching and facilitation to ensure the success of the site. The Associate Quality Specialist is accountable for the Quality Systems within the site. Primary activities/responsibilities: Provides to the site, knowledge and experience in Quality Systems and/or Operational Quality, including the following i.e. Deviation/NOE/LIR coaching; GCM coaching, environmental monitoring program, sterile assurance, customer complaint investigations etc. Uses knowledge to improve Quality Systems, provide continuous improvement and execute tasks. Understands and applies regulatory / compliance requirements to their role. Responds to standard requests from customer needs. Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines. Participation in inspections of Site by Divisional / Regulatory Bodies / third parties. Ensure supply of high quality product through the implementation and oversight of the Quality Management System for the site. Ensure the highest Quality, Compliance and Safety standards. The Senior Quality Specialist will participate and comply with the MMD Quality Management System (QMS) requirements, including ownership. Responsible for driving a culture of Continuous Improvement by deploying Six Sigma tools. The Associate Quality Specialist will have proven capability in development of Quality Systems as an active member, across cross functional teams, to deliver process improvement. Model the Leadership behaviours and understand the MPS principles to drive a culture of continuous improvement building a High Performance Organisation. Job Experience: 1 -3 years’ experience in the Pharmaceutical industry or a similar operating environment which includes experience in a Quality function. Demonstrated knowledge in one or more pharmaceutical and/or chemical manufacturing operation (i.e. quality, science etc.) Operational experience of at least 4 QMSs. Degree or 3rd level qualification (Science, Quality. Quality Assurance knowledge, from both operational and educational experience, is required. Demonstrated use of Leadership Behaviours. Knowledge and experience in interpreting current regulatory requirements and providing support to the site. Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance. Demonstrated ability to work and succeed within teams. Demonstrated ability to drive the completion of tasks. Advanced PC skills such as Excel, Word, PowerPoint. Demonstrated ability to maintain and strengthen trust relationships with people on all levels. Proven decision making capability with accountability and responsibility. Demonstrated ability to solve problems. Lean Six Sigma Yellow Belt or suitable alternative. Key Behaviours : Leadership Behaviours: Focus the entire organization on delivering value for customers, including patients, by understanding and meeting their needs. Collaborate: Actively listen and seek to understand differing perspectives; work together to achieve the common goals of the client. Act with Candor and Courage: Speak openly, honestly and with conviction; have the courage to take appropriate risks and make difficult decisions. Make Rapid, Disciplined Decisions: Make timely decisions at the right level with the right data, and support them once made. Drive Results: Set clear performance standards; overcome obstacles; hold ourselves and others accountable for achieving results. Demonstrate Ethics & Integrity : Adhere to the highest standards of trustworthy and ethical behaviour in all interactions and hold others to the same standards; comply with all laws, policies and regulations; identify and address ethical issues without hesitation. Build Talent: Build diverse talent with the capabilities necessary to succeed in our markets; inspire, reward and develop to ensure individuals reach their potential; make tough calls when necessary. Interested candidates should send their CV to audrey.mccarthy@peglobal.net or call 0214297900. Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. This job originally appeared on RecruitIreland.com.

1985 days ago