Senior Specialist, QA Operations DSP

SUMMARY
The role will be responsible for the Quality oversight of the Downstream manufacturing of monoclonal antibody(ies) produced at Incyte new large scale biological manufacturing facility at Yverdon-les-Bains, Switzerland.
The role will cover Downstream manufacturing and Buffer solutions preparation.
He/she will ensure a strong collaboration with other Bioplant functions and will promote compliance and continuous improvement while supporting the on-time supply of products.

DUTIES AND RESPONSABILITIES

• Manage the day-to day quality oversight of the DSP manufacturing and buffer solutions preparation.
• Review manufacturing SOPs to ensure compliance with Incyte Policies and regulatory requirements.
• Ensure compliance of manufacturing activities with cGMPs and approved procedures.
• Review, approve and ensure maintenance of Material and Product specifications.
• Review and approve manufacturing Master Batch Records.
• Perform batch record reviews within defined timelines and recommend batch disposition.
• Manage & Approve deviations and investigations.
• Recommend and approve CAPA plans and ensure implementation in area of responsibility.
• Review, assess and approve implementation of changes in the area of responsibility.
• Support the collect and compilation of data for the preparation of Annual Product Quality Reviews.
• Maintain and Control the Product Batch records filling and databases.
• Lead or contribute to the elaboration of risk assessments.
• Provide ad-hoc support to DSP equipments’ qualification.
• Support the Release of raw materials.
• Conduct internal and external audits.
• Represent QA function in manufacturing routine operational meetings.
• Contribute to the design and improvement of Quality processes.
• Support Inspection readiness activities and represent QA function for DSP related matters during Health Authorities inspections.
• Promote the understanding and application of Good Manufacturing Practices (cGMPs).
• Work closely with manufacturing department in order to foster prevention and anticipation of issues and the timely handling of unexpected events.
• Interpret GMP, general regulatory requirements and Quality systems regulations in the area of manufacturing and ensure implementation as applicable.
• Performs all responsibilities in accordance with company policies, procedures, applicable regulations and safety requirements.
• Stay current with the applicable regulations and promote Quality across the Incyte organization.

REQUIREMENTS

• Academic degree in natural or applied sciences (chemistry, biotechnology, engineering, pharmacy).
• Firsthand experience of min 5 years in Quality Operations for pharmaceuticals at manufacturing sites.
• Thorough knowledge in cGMP and international regulatory requirements.
• Expertise in Biotechnology products.
• Experience in dealing with International inspections.
• Strong analytical and problem solving skills.
• Good verbal and written communication skills with well-structured communication.
• Compliance focused.
• Auditor qualification is an asset.
• Fluent in French written and spoken (the company language) and ideally good level in English.
  

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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