Specialist / Senior Specialist, Global Commercial QA Packaging & Distribution

☞ Incyte

View: 139

Update day: 26-03-2024

Location: Morges Vaud VD

Category: Sales

Industry: Medical Devices Biotechnology Pharmaceuticals

Position: Associate

Job type: Full-time

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Job content

Summary

The Specialist / Sr Specialist Commercial QA, Packaging & Distribution will act as the primary QA counterpart for Secondary packaging and Distribution activities in EU, UK and Switzerland.

Duties And Responsabilities
  • Be the primary QA contact for products launches in line with regional scope.
  • Ensure implementation of Change Controls within product in scope (new commercial product and new markets introduction).
  • Support new product submission in and outside of EU for secondary packaging CMO.
  • Ensure implementation and maintenance of Packaging & Shipment Specifications.
  • Ensure secondary packaging validation activities for the introduction of new commercial products and new markets (ambient and cold products).
  • Support and maintain the qualification status of Cold Chain Supply for commercial products.
  • Coordinate and maintain distribution risk assessment for approved shipping lanes.
  • Ensure on time issuance and assessment of storage or distribution related temperature excursions.
  • Ensure implementation of changes at secondary packaging CMO.
  • Execute CMOs and Distribution Partners audits.
  • Review and approve MPRs, Serialization Data and packaging component Artworks and Proofs.
  • Perform batch disposition for finished products and coordinate with QP/RP for final release.
  • Ensure on time issuance, assessment and close out of packaging or distribution related deviations and returns.
  • Coordinate the execution of the Annual Mock Recall exercise for commercial products.
  • Coordinate the collect of data for packaging CMOs and perform the Annual Product Quality Review.
  • Record, assess and reconcile Product Quality Complaints.
  • Perform 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.

Requirements
  • Bachelor or Master degree in Life Sciences, medical technologies or engineering.
  • Minimum of 5 years work experience in pharmaceutical industry or scientific related, with at least 3 years in a QA department.
  • Good Interpersonal skills.
  • Strong work ethic and compliance.
  • Good verbal and written communication skills with well-structured communication.
  • English fluency written and spoken (the company language), German is an asset.
  • Travel up to 15%.
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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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 .

You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.

You can learn more about Incytes 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, Incytes data protection officer, and your supervisory authority (if applicable).

Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights.
Department: Global Quality Assurance Location: Incyte Biosciences Technical Operations Sàrl - Morges
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Deadline: 10-05-2024

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