Position: Associate

Job type: Full-time

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Job content

Summary

The role will be responsible for the Quality oversight of commercial manufacturing and testing activities for the assigned large molecules/Biologics products (Drug substance to Drug product).

Duties And Responsabilities
  • Manage the day-to day quality oversight of the commercial supply chain
  • Ensure compliance of Products by reviewing, approving and ensuring maintenance of Material and Product specifications,
  • Perform risk based Batch Record Reviews and releases of commercial batches,
  • Manage & approve deviations and investigations,
  • QA lead for OOS, OOT investigations,
  • Ensure and monitor implementation of Changes at CMOs,
  • Ensure and monitor implementation of CAPAs at CMOs,
  • Oversee for Quality Process and method validation activities as part of the product lifecycle
  • Quality Oversight of Stability Programs for commercial products,
  • Support or lead external audits according to Incyte audit program,
  • Collect and compile data for the preparation of Annual Product Quality Reviews,
  • Maintain and Control the Product Batch records filling and databases,
  • Support the CMC group for regulatory submissions and follow-ups,
  • Maintain Quality and Technical Agreements with the applicable service providers of the commercial supply chain,
  • Ensure inspection readiness at assigned CMOs,
  • 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,
  • Cooperate with the Supply Chain, CMC, QC and RA functions in matters relating to commercial Product.

Requirements
  • Academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering);
  • Firsthand experience of min 5 years in Quality Operations for pharmaceuticals;
  • Thorough knowledge in cGMP and US regulatory requirements;
  • Knowledge and preferably some expertise in Biotechnology products;
  • Audit experience;
  • Strong interpersonal skills;
  • Strong verbal and written communication skills with well-structured communication and presentation ability;
  • Ability to manage multiple on-going projects;
  • Results focused which may require negotiating skills, empathy, diplomacy, common sense;
  • English fluency written and spoken (the company language);
  • Travel, up to 20%
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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Department: Global Quality Assurance Location: Incyte Biosciences Technical Operations Sàrl - Morges
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Deadline: 10-05-2024

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