Compliance Specialist

2 weeks ago

Carlow Town Co Carlow, Ireland PE Global Full time

The role: PE Global is currently recruiting for a Quality Compliance Specialist on behalf of a leading pharmaceutical company based in Carlow. This is an initial 11-month contract role. Description: Responsible for supporting the Engineering Department in a GMP and Sterile Environment. Ensure that objectives are effectively achieved, consistent with requirements to ensure compliance, safety and reliable supply to our customers. Responsibilities: Direct and/lead deviations, out of tolerance conditions and unexpected results, conducting failure analysis, root cause determination and implementing corrective actions. Preparation and analysis of Engineering metrics reports to trend for improved operational efficiencies. Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so. Documents will include SOPs, SWIs, training documents, JSAs, PM's and change controls. Accountable for leading investigation analysis, identifying true root cause, identifying gaps and actions to close gaps. Collaborate with Engineering colleagues and other departments particularly IPT, Quality, EHS, Technical Engineering in completion of tasks. Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions. Work collaboratively to drive a safe and compliant culture in Carlow. Support Audit Readiness activities Education and Experience: 3+ years experience in a pharmaceutical or a highly regulated environment. Sc. Degree or other qualification in Science, Engineering or a related field. Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices Report, standards, policy writing skills required Sterile filling processes and equipment experience preferred. Proficiency in Microsoft Office and job-related computer applications required Lean Six Sigma Methodology experience desired 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 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. Skills: quality compliance GMP

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