QA Compliance Specialist

2 weeks ago

Carlow Town Co Carlow, Ireland Life Science Recruitment Ltd Full time

QA Compliance Specialist RK22831 Contract 11 months Carlow Hybrid Were currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Tipperary. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. This role will be 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. Duties: 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. May be required to perform other duties as assigned Support Audit Readiness activities Experience and Education: Third Level Degree qualified in a Science/Engineering or related discipline. 3-5 years prior related work experience ideally in a manufacturing, preferably GMP setting. GMP Audit experience in the pharmaceutical industry Experience with documentation such as SOPs, SWIs, training documents, JSAs, PM's and change controls If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information. Skills: GMP Quality Assurance Documentation

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