Quality Systems Specialist

The role: PE Global is currently recruiting for a Quality Systems Specialist on behalf of a leading pharmaceutical company based in Cork. This is an initial 11-month contract and a shift role. Description:

• This position within the QA department will provide Quality oversight, support and knowledge to activities relating to Quality Systems across the site and in meeting the priorities of: Compliance, Supply, Strategy and Profit Plan.
• The Quality Specialist will have proven capability in development of Quality Systems as an active member, across cross functional teams, to deliver process improvement. The Quality Specialist will model the Leadership behaviours and understand the MPS principles to drive a culture of continuous improvement building a High-Performance Organisation.
• The Quality Specialist will participate and comply with the Quality Management System (QMS) requirements, including ownership as required.
• The role is a shift, full time onsite role providing quality oversight to Operational areas. This role is integrated in the production area. The shift is 5/2, week 1 is M/T/F/S/S all 11-hour days. Week 2 is W/T 11.30 hr days.

Responsibilities:

• Provides to the site knowledge and experience in Quality Systems and/or Operational Quality, including the following i.e. Quality Notifications/ Investigations/ Change Management, environment monitoring programs; sterility assurance/low bioburden manufacturing; etc.
• Uses knowledge to improve Quality Systems, solve problems, provide continuous improvement and execute tasks.
• Acts as a resource to colleagues with less experience in Quality Systems and/or Operational Quality.
• Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes.
• Required to be proficient in Quality approval and oversight for Commissioning and Qualification activities (IQ/OQ/PQ).
• Interprets customer needs, assesses requirements and identifies solutions to non-standard requests.
• Makes decisions within guidelines and policies which impact Product Quality, Projects and Quality Systems.
• Provides compliance contribution to project teams and leads small projects.
• Coaches and guides colleagues within the site.
• Supports Corporate Quality to ensure actions related to Quality Systems at the site are executed.
• Participation in inspections of Site by Divisional / Regulatory Bodies / third parties together with follow up actions where applicable.
• Participate in GMP Walkthroughs.
• Deviation Management & Change Control approval.
• Ensures supply of high-quality product through the implementation and oversight of the Quality Management System for the site.
• Champion the highest Quality and Compliance standards for the site.

Education and Experience:

• Degree or 3rd level qualification (Science, Quality).
• Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation.
• 5 years’ experience in the pharmaceutical industry or a similar operating environment which includes experience in a Quality function.
• Quality Assurance SME knowledge, from both operational and educational experience, is required.
• Knowledge and experience in interpreting current regulatory requirements and providing independent support to the site.
• Advanced PC skills such as Excel, Word, PowerPoint.
• Stakeholder management of multiple decision makers, auditors, cross functional teams by demonstrating the ability to maintain and strengthen trust relationships with people on all levels.

Interested candidates should submit an updated CV. Please click the link below to apply, call Kellie on or alternatively send an up to date CV to. ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland.*** Although it is not possible for us to respond to all applications, we at PE Global will do our utmost 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. Skills: quality systems, GMP, quality assurance, deviations, CAPAs #J-18808-Ljbffr