Specialist, Sr Specialist, QA Engineering

SUMMARY

The Specialist / Senior Specialist, QA Engineering supports the Engineering activities at Incyte large scale biological manufacturing facility at Yverdon-les-Bains, Switzerland.

He / She will maintain a strong collaboration with other Bioplant functions and will promote compliance, continuous improvement and Quality culture.

DUTIES AND RESPONSABILITIES

·         Ensure quality oversight of the Commissioning & Qualification, Utilities, Calibration and Maintenance activities

·         Ensure quality oversight of Environmental monitoring and Utilities trend review

·         Partner with engineering and QC departments in order to foster prevention and anticipation of potential issues as well as the timely handling of unexpected events

·         Review and approve SOPs to ensure efficiency of the process and compliance with Incyte Policies and regulatory requirements

·         Ensure compliance of engineering activities with cGMPs and approved procedures

·         Review and approve deviations and investigations in the area of responsibility. Escalate as appropriate to management major / critical issues

·         Recommend and approve CAPA plans and ensure timely implementation

·         Review, assess and approve implementation of changes in the area of responsibility

·         Contribute to the elaboration of risk assessments in the area of responsibility

·         Contribute to continuous improvement initiatives in the area of responsibility

·         Support Inspection readiness activities and represent QA function for Engineering department and Environmental Monitoring related matters in Health Authorities inspections

·         Support the internal audit and GMP tour programs

·         Foster compliant and right first time activities

·         Foster the understanding and the application of Good Manufacturing Practices (cGMPs) by Bioplant employees

·         Act as back-up of the QA CSV

REQUIREMENTS

·         Bachelor’s Degree in relevant field such as Chemical Engineering, Bio-engineering, Bioprocessing

·         Advanced degree preferred

·         Speak, read and write in French and English

·         Minimum of 5 years in a Quality Assurance role in a biopharmaceutical manufacturing environment

·         Prior successful experience in equipment Qualification and Computerized System Validation

·         Thorough knowledge of biotechnology processes

·         Demonstrated proficiency in good practice requirements cGMP as well as biopharmaceutical industry regulations and standards related to qualification and validation

·         Proficiencies with the quality systems and, preferably, with business processes associated with automation and integration of testing and production systems

·         Experience in Health Authorities inspections

·         Ability to make pragmatic and compliant decisions

·         Strong result orientation and committed team member

·         Flexibility and ability to travel

·         Good written and verbal communication skills.

DELEGATE: Manager, Quality Operations and Engineering

Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.

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