The Intern will be part of the Small Molecule (SM) Commercial Manufacturing QA team responsible for the Quality oversight of commercial manufacturing activities associated with SM Drug substance, Drug Product and primary packaged Product.
Duties And Responsibilities
- Coordinate the collection of CMOs Annual Product Quality Review (APQR) reports and support the issuance of Incyte APQR Reports,
- Implement Quality & Technical Agreements (QTA) template(s) for SM Commercial Manufacturing activities matching (if applicable) the current Biologics Manufacturing QA team QTA template(s).
- Review and harmonize classification of QA related documents in eDMS,
- Support vendor management activities such as update of Veeva Organizations and collection of vendor statements,
- 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,
- 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.
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