Job Description
The role: PE Global is currently recruiting for a Senior MS&T Scientist on behalf of a leading biotech company based in Dublin North. This is an initial 11-month contract role. Job Purpose: The Quality Assurance Specialistensures adherence to Good Manufacturing and Documentation Practices, Quality Manual and local procedures. The Quality Assurance Specialist spends significant time on the shop floorin a team environmenttoprovide quality coaching and guidance, to enabledocumentationto becompleted right the first time, and to ensure compliance with cGMPs and regulatory requirements. Responsibilities: Provide direct Quality support to production and support areas. Provides presence on the shop floor to support complianceand data integrity. Review and approve GMP documentation/data for accuracy and completeness. Reviewand approve executed production documentation such as electronic batch recordsandlogbooksto ensure accuracy and compliance withcGMPsand company proceduresand ensures completion ofproperremediationof errors. QA support, review and approval of C&Q, Performance qualification (PQ) & Process Validation documents. Support sustaining activities such as change management, deviations, CAPAs, equipment requalification, periodic review, site maintenance & Calibration Programs. Provides support to internal audits and regulatory inspections. Collaborates with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans. Qualification and Experience: Bachelor degree, in a scientific or engineering field. 3 years of relevant post-degree experience in a GMP environment: manufacturing, laboratory, quality, operations, technical, or regulatory function. MES experience is desirable Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work/ upskill/coach a team environment. Knowledge ofcGMPsand of regulatory requirements as they apply to the pharmaceutical field. Technical writing skills. Lean Six-sigma and problem-solving tools. 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 GMP lean tools CAPA