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.
Responsibilities
* Able to understand the basics of a new system and process, the client’s way of working, and the training strategy
* Develop and deliver training materials per client’s requirements while ensuring compliance
* To 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 topics
* Assign 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 unclarities
* Update training materials as per the feedback received from SMEs
* Develop, review, and update SOPs to comply with regulatory standards
* Develop Work Instructions and Handouts as per industry best practices
* Ensure training and SOPs are written clearly and in compliance with the language
* Manage the SOP lifecycle, version control, approvals, and periodic reviews
* Ensure all users are trained on the new and updated training materials & SOP in timely manner
* Knowledge of GMP, GCP, GLP, and Pharmaceutical Regulation (EMA, ICH, FDA, etc.) is required
* Strong experience with 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.
Qualification:
* Atleast Bachelor's degree required in for Pharmaceutical: science, engineering, or related field (advanced degree preferred).
* Veeva Vault RIM certification is a plus.
* Experience working in an Agile/Scrum environment