For our client, based in Switzerland, we are currently looking for a skilled Consultant for QMS and CHAD (Chemical and Analytical Development) [remote] (m/f/d)

• Location: Remote

General Information:

• Duration: 01.02.2025-31.01.2026

• Location: remote

• Workload: 100%

• Contract Freelance. If consultant is based in Switzerland it’s also possible to get employed by us (swiss payroll)

Tasks & Responsibilities

• Quality Management System (QMS) and contributing on Global or CHAD SOP periodic re-views and gap assessments (reviewing/authoring based on current Health Authority, ICH and GMP guidance). Updating CHAD document templates and performing associated training on SOP/process updates. Updating and defining new analytical business processes including accelerated projects, and industry approaches/benchmarking for TRD activities.

• Preparation of quarterly CHAD CH OOS trend reports, and consultancy on compliance and GMP topics, including during audits.

• Consultancy on the set-up of the Freeway RIM Vault configuration for CHAD.

• CHAD CN training, support and governance for SM late-phase development work and pilot projects. Provides expertise on SM analytical development, method troubleshooting, specifi-cations, and supports PAMR / PASR meetings on CHAD CN projects.

• Conducting specific launch and transfer activities to NTO/CMO sites, including:

• Consultancy services for HA inspection(s): focus on analytics aspects for commer-cial/registration, pre-approval inspections, advice in response to analytical HA ques-tions.

• Support the development of templates and processes and tools (e.g. Peregrine SOP and Analytical Strategy Documents)

• Training and use of transfer waivers / transfer kits where possible.

• Function as supporting AE as and when required.

• Advising on analytical lifecycle management processes and requirements in line with new ICHQ14/Q2 guidance, validation, transfer, method performance trending, project challenges and regulatory hot topics. Advising on documentation processes and method optimizations for cost, efficiency, green future-proofing, and safety.

• Supporting deviation/OOS investigations, and troubleshooting across global TRD/CHAD la-boratories, providing advice, relevant training and expert consultancy (ad hoc) for OOS events.

• Consultancy on the characterization and transfer of reference standards (including new mo-dalities).

• Support for early-phase projects and EMP outsourced projects and management/tracking processes on “as needs” basis (i.e. Analytical GMP oversight and establishment of methods, specifications and related transfer/validation, analytical batch record review, AUC, NSR, and QC activities as required).

Must Haves

• Expert knowledge of ICH and various regional regulatory authority guidelines and requirements, analytical and organic chemistry
• Knowledge of quality and compliance, GMP and organizational aspects.
• Knowledge of Novartis SOPs at the current time in the area of analytics covering global TRD-NTO business activities and processes such as analytical method validation, transfer, specification setting and regulatory submissions.

Did we catch your interest?

The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).

Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.