SimoTech provides manufacturing automation and IT systems engineering, project management and validation services. We partner with life sciences companies to design, build, operate and optimise critical process automation systems that deliver fast track project delivery, operational efficiency, improve manufacturing agility and achieve regulatory compliance.
Why SimoTechWhat is it like to work at SimoTech? With a strong collaborative teamwork culture based on respect, trust and excellence, we play a critical partnering role to our clients' life-changing supply of products to patients. In return, there is excellent salary, career progression, educational support and much more.
QA Compliance Specialist 1497SimoTech has a new opportunity for a Quality Assurance (QA) Compliance Specialist to join our team supporting our client, a leading innovator in the healthcare industry in Cork.
The successful candidate will have 4+ years' experience providing QA support in a CSV, MES, OSI PI or Labs environment in the pharmaceutical industry. In this role, you will support several long-term projects including the digitalisation of the laboratory system platform and the introduction of OSI PI to the site, ensuring that all work and documentation related to the projects meets industry standards and regulations. The role offers a hybrid working model.
Key ResponsibilitiesBe a specialist in Quality Assurance systems and processes in the Life Sciences industry.Support validation activities such as review and approval of CSV related documentation including qualification protocols, reports, FAT/SAT documents, SOPs, Master Validation Plans, IQ, OQ, PQ, URS, SDS etc.Create QA related documents such as SOPs, QA reports and reviews, change management reviews.Carry out investigations on errors or discrepancies found in reviewed documentation related to validation testing, protocol errors, etc.Draft and conduct risk assessments.Assist project teams with ensuring that their work is completed in compliance with industry standards and regulations, including 21 CFR Part 11 and GAMP5.Work with multiple departments and stakeholders including operations, automation and vendors to ensure completion of project goals and objectives.Qualifications4+ years' experience supporting Quality Assurance related activities in projects relevant to MES, OSI PI or Labs in a Life Sciences environment.Strong understanding of industry regulations and standards on FDA 21 CFR Part 210 and 211, Eudralex Annex 11 and GAMP5.Experience of implementing data integrity ALCOA+ principles.Knowledge of compliance systems such as Veeva Vault, Trackwise, Compliance wire, Kneat.Working knowledge of risk assessments.Excellent verbal and written communication skills.Strong analytical and problem-solving skills.Ability to work as part of a team as well as on your own initiative as required.What SimoTech Can OfferRole provides a high degree of autonomy to allow the successful candidate to reach their full potential.Develop new skills and enhance technical ability by working with innovative technologies in a multi-disciplined environment.Opportunity to work with large corporate clients on exciting capital projects.By submitting my data (CV), I consent to SimoTech collecting and storing my personal data, as outlined in the SimoTech Privacy Statement which I have read.
#J-18808-Ljbffr