Our client is a global biopharmaceutical company located near Neuchatel, Switzerland
Focused on research, development, and delivery of innovative medicines across several therapeutic areas, including oncology, hematology, immunology, and cardiovascular disease
The position holder will support the development and implementation of strategies that ensure Global Commercial Supply is maintained in a constant state of compliance. This position regularly works cross-functionally with Manufacturing, Quality, Logistics, Facilities, Drug Product Development and Vendors.
May be assigned Subject Matter Expert (SME) role for a defined validation/qualification area
Ensure cleaning processes are qualified, validated and maintained in compliance with local policies, guidelines, and procedures during their lifecycle.
Author and when required review validation documents, including validation plans, protocols, reports, traceability matrix and summary reports.
Execute validations for cleaning across the site.
Coordinate activities interfacing with multiple sites, departments, and external vendors.
Lead/participate in risk assessments and risk management teams.
Review change controls and maintenance interventions, evaluate the impact upon qualified systems & validated processes, and document required actions.
Maintain procedures governing validation to ensure they are in compliance with corporate policies and regulatory requirements. Participate in the development and maintenance of the local site procedures.
Participate when required during internal and external audits for which they are a SME, by answering questions, reviewing qualifications and validations with auditors, and providing documentation.
Participates in/leads projects and initiatives and contributes to continuous improvement exercises.
Our client is looking for someone who has:
Degree in Engineering/Technical discipline or experience equivalent.
Experience (at least 5 years) in validation is required, with a particular focus on cleaning validation for small molecules
Familiarity with current international regulatory regulations, cGxP requirements and best practices, including 21 CFR part 11, 210 and 211, Annex 11n, EU-GMP guidelines and GAMP
Good communication skills in English with stakeholders and outside vendor groups
Automation knowledge advantageous
Team player: the ability to interact effectively with the team and customers
Proactively identifies problems and recommends solutions
Fluent in English and French
***This position has now been filled, please contact firstname.lastname@example.org to be informed of future similar positions***