Training Specialist ( RIMs , SoP Author, Regulatory)

Smartedge’s Client is looking for an individual to help with their Training Specialist ( RIMs , SoP Author, Regulatory) @ Remote (EU) Job Description : We are looking for a Training and SoP Author Specialist with experience in the Life Sciences pharmaceutical industry to ensure compliance with regulatory requirements, including 21 CFR Part 11, GxP, and Annex 11. The ideal candidate should have expertise in Regulatory Information Management applications, with a strong understanding of Veeva Vault RIMS being a plus. ResponsibilitiesAble to understand the basics of a new system and process, the client’s way of working, and the training strategyDevelop and deliver training materials per client’s requirements while ensuring complianceTo be able to handle various platforms, namely Learning Management Systems (Veeva Vault Training, Cornerstone OnDemand) for training delivery, content development tools (Articulate 360, Adobe Captivate), SOP and Document Management Systems (Documentum), Assessment and Evaluation tools (Google Forms & Microsoft Forms), Virtual Training and Collaboration Tools (Microsoft Teams, Zoom, Webex Training)To be able to collect and document the training and SOP aspects discussed in the focus topicsAssign content to the correct training module (functional vs. process, training vs. SOP)Collaborate with different departments to identify training needs, gaps, and raise questions in case of unclaritiesUpdate training materials as per the feedback received from SMEsDevelop, review, and update SOPs to comply with regulatory standardsDevelop Work Instructions and Handouts as per industry best practicesEnsure training and SOPs are written clearly and in compliance with the languageManage the SOP lifecycle, version control, approvals, and periodic reviewsEnsure all users are trained on the new and updated training materials & SOP in timely mannerKnowledge of GMP, GCP, GLP, and Pharmaceutical Regulation (EMA, ICH, FDA, etc.) is requiredStrong experience with LMS, RIMS, and DMS systems is necessary.General tasks:Understand new systems, processes, client’s way of working, and training strategy.Develop and deliver compliant training materials per client requirements.Handle platforms for training delivery, content development, SOP and document management, assessment and evaluation, and virtual training and collaboration.Document training and SOP aspects discussed in focus topics. Experience:Bachelor’s or Master’s degree in Pharmaceutical, Computer Science, IT, Engineering, or a related field.10+ years of experience in Computer System Validation (CSV) in the pharmaceutical, biotech, or medical device industry.Strong knowledge of GxP, 21 CFR Part 11, GAMP 5, Data Integrity, and Annex 11.Experience in validating SaaS applications used in the pharmaceutical industry.Familiarity with Veeva Vault RIMS, QualityDocs, or Submissions Archive is a plus.Excellent documentation skills and experience with validation lifecycle documentation.Ability to work independently and collaborate with cross-functional teams. If this sounds like a role you would be interested in or if you know someone in this field. Connect with me or email me at pavitra.b@smartedgesolutions.co.uk Alternatively, you can call me on Tel: +44(0)203 500 2108.