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CQA Specialist Warehouse (m/w/d) - In Teilzeit

Req # JR - 029049 Location Höchstadt an der Aisch, Bavaria Job Category Quality Control Date posted 10/22/2020

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ESSENTIAL DUTIES AND RESPONSIBILITIES

The job holder is named1 and act as Responsible Person (QP) for Baxter Deutschland GmbH in Höchstadt a. d. Aisch and is responsible for:

  • Ensure Good Distribution Practices (Ensure appropriate storage- and delivery conditions)
  • Ensuring contact with Competent Authorities
  • Check returns for compliance to legal requirements, decide on further disposition
  • Release products for distribution in Germany after verification they comply with all applicable requirements, where applicable (in cooperation with the manufacturing plant, after review of temperature documentation or release by the local authority e.g. PEI) ; Ensure release-related processes and procedures are in place ; local Hold Coordinator
  • Execute FA related activities (Decision of further disposition)
  • Ensure establishment and maintenance of required license (e.g. Wholesaler)
  • Review and implementing of Corporate Quality Systems including local requirements to CQA and W&D
  • Support the local team in QA-related questions, delivery-complaints and projects
  • Support preparation and shipment of demonstration samples for CQA, RA or Marketing

ACTING AS SUCH, SHE IS NOT BOUND BY INSTRUCTIONS IN CASE SHE SEES THE RESPONSIBILITY AS DEFINED BY LAW COMPROMISED.

After acceptance of the Government of Oberfranken, the job holder will be the named Responsible Person for the Wholesaling Activities for Baxter Deutschland GmbH, site Höchstadt a. d. Aisch, according to German AM-HandelsV (§ 52 a Abs 1 AMG ; GDP-LL ; EU-Richtlinie 2001/83/EG Art. 79)

Compliance W&D:

  • Support implement of Good Distribution Practice in the warehouse Höchstadt
  • Support of the CQA-team, warehouse Höchstadt team and Regulatory Affairs team in label checks, submission implantations, questions, deviation management regarding products and projects; train the team on QA and GDP aspects
  • Regularly inventory and quality check on broken cartons products
  • Performing quality decisions regarding Replenishment complaints
  • Support Replenishment shipments regarding temperature control
  • Check weekly temperature monitoring data of warehouse
  • Support Supplier Qualification
  • Perform internal checks and internal Assessments, including validation status, Pest Control results, calibration, maintenance, logbooks and discard of expired material
  • Perform frequent checks on additional client information included in the deliveries

Ensure JDE and WMS (Swisslog) related processes and procedures:

  • Performing and documenting temperature-releases in the warehouse Höchstadt
  • Clarification of deviations during receiving of products and missing receivings with the plants, logistics and CQA
  • Release and bookings in WMS (Swisslog), where needed with check digits
  • Perform final approval of returns in WMS (Swisslog)
  • Check of receipt documentation received from dedicated warehouse worker
  • Manage QC-status in WMS (Swisslog)
  • Manage QC-Status in JDE for TS
  • Correction and bookings in JDE

Support release products for distribution in Germany:

Preparation, checking and shipment of samples to Paul Ehrlich Institut (PEI) in close collaboration with the Specialist CQA. Manage retention samples for PEI.

JOB REQUIREMENTS

Education

The function requires a science degree and previous experience in a pharmaceutical company, QA function preferred.

Experience

Number of years of experience:

2 to 5 years

Field of expertise:

Preferably in pharmaceutical – quality, production or distribution.

Functional/specific competencies

  • Excellent interpersonal and communication skills
  • Ability to liaise with the different functions involved
  • Excellent ability to coordinate and prioritize work

Languages:

Germant and English fluent, any other additional language would be an asset.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] and let us know the nature of your request along with your contact information.

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