KPC International - Excellence from Concept to Completion
KPC International began operations in 2001, our team of Engineers and Scientists have helped our clients achieve project success all over the world within the pharmaceutical and biopharmaceutical space.
We specialise in Plant Facility Start-Up from Strategy and Planning to Execution, through to Operational Readiness. We are proud to support our clients in delivering their life changing products to patients.
The Deviation Specialist will be part of a team that is currently established to own and investigate deviations at a large scale mammalian cell culture facility.
Represents 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.
Key Responsibilities
Responsible to own, author, record 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.).
Contribute 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.
Essential Skills and Experience
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 Organisational 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.
KPC - International offers an inclusive environment where you can broaden your experience, perspective and skills to help make an impact on the lives of others.
KPC – International is an Equal Opportunity Employer.
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