QA Validation Specialist

3 days ago

Cork, Ireland PE Global Full time

The role: PE Global is currently recruiting for numerous QA Validation Specialists on behalf of a leading API company in Cork. These are all initial 12-24 month contract roles. Responsibilities: Maintenance of a strong Quality culture throughout the project through operational activities. Provide QA support for risk based verification activities in the capacity of Quality Assurance Subject Matter Expert. Review and approval equipment/utilities verification documentation from design to post execution. Lead and/or participate in the investigation of non-conformances and follow-up corrective/preventative actions in compliance with quality procedures, policies and regulations. Participate in verification quality risk assessments and provide quality oversight to ensure verification quality risk assessments are effectively maintained/controlled. Ensure and participate in the Quality Assurance support to internal manufacturing and technical groups. Review and approval of functional area documentation (SOP, Work Instructions, Criticality Assessments, technical report and protocols). Authoring, review and approval of QA validation -related procedures. Review and approve Validation protocols as required. (Examples include cleaning, process, and method validation). Support the vendor quality management programme. Complete Audits as required. Develop and report quality metrics for validation/verification. Provide quality oversight of calibration and preventative maintenance criticality assessments as required. Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements. Education and Experience: Primary Degree in Science 3-5 years experience in Quality/validation environment. Excellent attention to detail Good communication, team work and problem solving skills The duties of this role are generally conducted in an office environment and in a pharmaceutical manufacturing environment. Good knowledge of relevant computer packages e.g. Trackwise, SAP and Vault Quality 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 assurance validation GMP compliance

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