Posted to MedZilla on 9/20/2017


ProClinical

Switzerland, Associate QA Manager/Senior QA Specialist (QA GDP) QA_CR_13365-MZ


 
 

A worldwide biotechnology company that operates in over 70 markets worldwide is looking for a Associate QA Manager to join their team in the Zurich area, Switzerland. The company specialises in neurological conditions and puts a great emphasis on teamwork and delivering biological products.

Job Role:

The Senior Associate, Quality Assurance Distribution is responsible for the oversight of the Commercial logistics department and distribution related procedures; support to the QA oversight of the Central Distribution Warehouses and QA handling of all Exceptions and Change Controls related to distribution of products.

Job Responsibilities:

Oversee from QA perspective all Commercial Logistics department activities and procedures

  • Support decisions relating to product distribution
  • Training of logistics team on GDP matters
  • Quality review of distribution related procedures
  • Development of QA owned distribution related procedures

Support QA supervision of the Central Distribution Warehouses

  • Participate in Audits and Quality Management Reviews
  • Update Quality Agreement and monitor partner's performance against it
  • Maintain frequent contacts with partner's QA organization to ensure alignment
  • Oversee partners' deviation and CAPA management;
  • Support and manage Change Controls

QA Management of 's Exceptions, CAPAs, Change Controls relating to distribution of products

  • QA review of distribution related issues and temperature excursion assessments
  • QA review of deviations and CAPAs
  • QA responsible for Change Controls
  • Oracle QA status changes for on hand product

QA Management of logistics processes related to recall

  • Support development of retrieval plan including distribution partner's communication;
  • Oversee returns process, shipments documentation, returned units' inspection and reconciliation
  • Manage Oracle QA status changes
  • Coordinate and supervise logistics partners and Logistics department activities and associated documentation

Job Requirements:

  • Minimum of 5 years of experience in pharmaceutical or biotechnology industries in GDP or GMP environment; QA or Regulatory experience preferred
  • Knowledge of deviation, CAPA and change control, QA management
  • Excellent communication skills, able to communicate at all levels of the organization
  • Assertive and diplomatic, able to influence without direct reporting line
  • Ability to work cross-functionally and in an international environment with people from multiple cultural backgrounds
  • Bachelor's degree in Supply Chain, Pharmacy or other

To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Courtney Russell on +44 203 8141 315 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.


Please visit our website at www.proclinical.com

 
 


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