Expert Quality Operations

Overview

SUMMARY:

The role will manage the Quality oversight of the manufacturing activities of monoclonal antibody(ies) produced at Incyte large scale biological manufacturing facility at Yverdon-les-Bains, Switzerland.

The role will ensure a strong collaboration with other Bioplant functions and will promote compliance and continuous improvement while supporting the on-time supply of products.

• Support the day-to-day quality oversight of the USP and DSP manufacturing, washing area and media / buffer solutions preparation activities (including on-the-floor presence in manufacturing classified area)
• Represent QA function in manufacturing routine operational meetings
• Operate in close proximity with manufacturing in order to foster prevention and anticipation of potential issues as well as the timely handling of unexpected events
• Review and approve manufacturing SOPs to ensure compliance with Incyte Policies and regulatory requirements
• Ensure compliance of manufacturing activities with cGMPs and approved procedures
• Ensure compliance of the manufacturing documentation management (logbooks, paper batch records, forms …)
• Ensure compliance regarding materials management in production (traceability, identification)
• Perform Batch Record Reviews and approval within defined timelines
• Anticipate M /E  review workload to ensure timely and efficient reviews
• Oversee manufacturing activities to identify compliance risk and implement appropriate preventive actions
• Lead and monitor the exception management process to ensure accurate first-time documentation by the Manufacturing team and timely review by the QA Operations team.
• Review & Approve manufacturing 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
• Lead or Contribute to the elaboration of risk assessments
• Contribute to continuous improvement:
  Perform GEMBA on-the-floor and track actions implementation
• Support Inspection readiness activities and represent QA function for Manufacturing department related matters in Health Authorities inspections
• Foster understanding and the application of Good Manufacturing Practices (cGMPs) by manufacturing Bioplant employees, target compliance right first time for operations.
• Drive continuous improvement of existing processes to enhance efficiency and achieve Right First Time
• Provide QA expertise and guidance to Manufacturing on complex quality topics, including (but not limited to) deviations, investigations, CAPAs, Change Controls and risk assessments.
• Provide training to Manufacturing personnel on Quality and GMP expectations, including (but not limited to) appropriate documentation and exception / investigation management practices, as part of onboarding and ongoing training activities.
• Act as backup for the QA Operations Supervisor during periods of absence, ensuring continuity and prioritization of QA Operations activities.
• 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
• Contribute positively to a strong culture of business integrity and ethics
• Act within compliance and legal requirements as well as within company guidelines

• A degree or equivalent experience in natural or applied sciences (such as Pharmacy, chemistry, biotechnology, engineering) is preferred
• Firsthand experience of min 5 years in Quality Operations for pharmaceuticals at manufacturing sites
• Thorough knowledge in cGMP and international regulatory requirements
• Understanding of biotech processes
• Experience in dealing with inspections
• Good analytical and problem-solving skills
• Good verbal and written communication skills with well-structured communication
• Compliance focused
• Auditor qualification is an asset
• Proficiency in French written and spoken (the company language) and a good level in English is preferred, but not mandatory

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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