Specialist Quality Operations

Overview

Summary:

The role will be responsible for the quality oversight of the manufacturing of monoclonal antibody(ies) produced at Incyte large scale biological manufacturing facility at Yverdon-les-bains, Switzerland. The role will cover all manufacturing departments.

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

• Manage 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)
• Perform Batch Record reviews within defined timelines and recommend batches disposition
• Review and approve manufacturing SOPs to ensure efficiency of the process and compliance with Incyte Policies and regulatory requirements
• Ensure compliance of manufacturing activities with cGMPs and approved procedures
• Ensure compliance of manufacturing documentation management (logbooks, paper batch records, FORMs...)
• Review and approve manufacturing Master Batch Records
• Review and approve manufacturing deviations and investigations. Escalate as appropriate to management major/critical issues
• Recommend and approve CAPA plans and ensure timely implementation
• Ensure compliance regarding materials management in production (traceability, identification)
• Review, assess and approve implementation of changes in the area of responsibility
• Contribute to the elaboration of risk assessment in the area of responsibility
• Contribute to the continuous improvement initiatives in the area of responsibility
• Perform GMP tour / GEMBA and track action implementation
• Represent QA function in manufacturing routine operational meetings
• Foster compliant and right first time operations
• 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
• Foster the understanding and the application of Good manufacturing Practices (cGMPs) by Bio Plant employees
• Partner with internal stakeholders to ensure efficient collaboration
• 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 , 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 guideline

• Academic degree in natural or applied sciences (Pharmacy, chemistry, Biotechnology, engineering)
• Firsthand experience of min 3 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 international inspections
• Strong analytical and problem solving kills
• Good verbal and written communication skills with well structured communication
• Compliance focused
• Internal 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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