GMP Quality Assurance, Intern

Incyte; Vaud; On-site; CHF 22,000 - 33,000; Full time

Job summary

Incyte in Vaud, Switzerland is seeking a Master student for a six-month internship in Commercial Manufacturing QA. The role focuses on quality oversight of CMOs, APQRs, vendor statements, and QA document classification in eDMS. You will work across QA functions and contribute to CAPA and KPI initiatives.

Fluency in English (B2) is required; French is a plus. The internship is 80–100% and supports the company’s quality management system and regulatory compliance.

Qualifications

• Master student in Chemistry, Biology or Pharmacy or equivalent.
• English fluency written and B2 spoken (the company language). French is an asset.
• Demonstrate ability to write technical documents.

Responsibilities

• Coordinate collection of CMOs APQR reports and support issuance of APQR reports.
• Support vendor management activities and update Veeva Organizations.
• Review and harmonize classification of QA documents in eDMS.
• Support collection of SM vendor batch documentation for batch disposition.
• Support management and monitoring of SCN, CAPAs, Product Complaints and KPI implementation.
• Cooperate with QA and other functions while adhering to policies and regulations.

Skills

Organizational skills

Communication skills

Diplomacy

Commitment

Technical writing

Education

Master's degree in Chemistry, Biology or Pharmacy

Job description

Overview

The Intern will be part of the Commercial Manufacturing QA team responsible for the Quality oversight of commercial manufacturing activities associated with Drug substances, Drug Products and primary and secondary packaged Products.

He / She will contribute to the maintenance and compliance of Incyte Quality Management System.

Duties And Responsibilities

• Coordinate the collection of CMOs Annual Product Quality Review (APQR) reports and support the issuance of Incyte APQR Reports.
• Support vendor management activities such as update of Veeva Organizations and collection of vendor statements.
• Review and harmonize classification of QA related documents in eDMS.
• Support the collection of SM vendor batch documentation to prepare Incyte batch disposition.
• Support the management and monitoring of Supplier Change Notification (SCN).
• Support the management and monitoring of internal and external CAPAs.
• Support the management and monitoring of Product Complaints.
• Support internal Key Parameter Indicator implementation and monitoring.
• Perform all responsibilities in accordance with company policies, procedures, applicable regulations and safety requirements.
• Cooperate with the Supply Chain, Commercial Operations, Regulatory Affairs, Small Molecule Clinical Manufacturing QA and Biologics Manufacturing QA functions.
• Contribute positively to a strong culture of business integrity and ethics.
• Act within compliance and legal requirements as well as within company guidelines.

Requirements

• Student in Master degree in Chemistry, Biology or Pharmacy or equivalent,
• Partial to full time six month internship (80 - 100 %),
• Good Organizational and communication skills, diplomacy, and commitment,
• Demonstrate ability to write technical documents,
• English fluency written and B2 spoken (the company language), French is an asset.

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.

Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.

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Learn more at: http://www.incyte.com/privacy-policy

The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here.

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You can learn more about Incyte’s data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority (if applicable).

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