Deviation Manager (6445)

Deviation Manager – 6445

Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a Deviation Manager for a 6-month contract with potential extension, based in the Valais area, Switzerland. This is a hybrid role with 3 days onsite and 2 days home office.

The Deviation Manager will be part of a team that is currently established to own and investigate deviations at a large-scale mammalian cell culture facility.

They will represent the Operations Unit, taking ownership of Deviations which arise; to investigate the root cause(s), the impact/potential impact on product and/or systems, and to define appropriate CAPA(s) as solutions.

Main Responsibilities:

·      Responsible to own, author and investigate Deviations.

·      Liaise with Subject Matter Experts (SMEs) and key stakeholders to establish the root cause(s) of deviations and the potential impact of said deviations.

·      Ensure proper investigational tools are used to systematically define the root cause(s) and contributing factor(s) (e.g., Fault Tree Analysis, Defense Analysis, Event & Causal Factors Chart, Fishbone Diagram, etc.).

·      To define appropriate CAPA(s), and associated Effectiveness Checks, as solutions to correct deviations and prevent future recurrence.

·      Ensure cGMP compliance through the investigation process, and to drive their quality records to completion and timely closure.

·      Support the business through ongoing change and process improvement activities. 

Qualifications and Experience:

·      Relevant working/residency permit or Swiss/EU-Citizenship required

·      Bachelor degree in chemistry, biotechnology, life science or related field.

·      Previous experience in Deviations and cGMP in a regulated pharmaceutical/API industry is a strong advantage.

·      Knowledge of biotech. manufacturing processes and analytical methods is an advantage.

·      Experience with Human and Organizational Performance & risk management approaches is an advantage

·      Fluency in English, both written and spoken. German is an advantage.

·      Technical writing & presentation/communication skills are key for the role. Demonstrated previous experience is a strong advantage.

·      Structured, focused and well-organised working attitude. Open-minded for new ideas and suggestions; agile, highly motivated and dynamically driven.

·      Ability to work with and lead a team of SMEs without formal authority, as well as to deliver projects working independently.