Validation Expert

Harvey Nash is looking for a Validation Expert for a 9 month project in Switzerland.

The candidate is responsible for implementing key elements of Process and Cleaning Validation to meet cGMP requirements on time, and with the right quality to ensure that programs are compliant with inspection agencies requirements and related SOPs.

You are responsible for

. Establishing, writing, and maintaining key elements of the Validation Master Plan for process and cleaning validation¨
. Supporting Process Validation Lead in executing and maintaining the VMP activities (process and cleaning validation)
. Partnering with Quality based on feedback (eg via division, regulatory inspections, changes in regulations) to establish and maintain common approach and translate that for the site
. Adhering to established procedurestranslating the critical process parameters and the process control strategy into a focused validation plan for process validation
. Reviewing and authoring validation protocols and reports; Supporting the execution at the shop floor
. Collecting and providing experimental data obtained during the validation activities, which will be used to prepare the related registration documentation
. Understanding potential risk areas/shortfalls and making sure that the assigned validation area is always inspection ready
. Validation Master Plan (VMP) elements that are assigned are completed and up to date
. Meeting established validation and revalidation milestones according to approved validation plans
. Delivering validation data that meet the target schedule and quality to support the required registration documentation
. Validation approach meets clients' QM requirements, health authority and industry standards
. Training curriculum up-to-date

Requirements

. Education (minimum/desirable): BSc. in Chemistry, Pharmacy, (Bio-) Chemical Engineering or Pharmaceutical Technology.
. Languages: English fluent in speaking and writing. French is an asset
. 5 years' experience in manufacturing/manufacturing science and technology/technical development/Quality
. Thorough understanding of manufacturing processes and related process equipment
. Strong working knowledge of quality systems and regulatory requirements across multiple health authorities
. 3 - 5 years' experience in executing process validation
. Expert in reviewing and writing technical reports
. Proven experience in a cross-functional environment (eg multi-site, technical development, other functions)
. Fundamental understanding of standard pharmaceutical analytical testing

Are you available immediately, have experience working within a Life Science company? Please send your complete CV (Word documents preferred) to (see below) For further details feel free to call me. I am looking forward to receiving your application.