Site Quality Source Technician
12.06.2019 | Employee | 100%

Site Quality Source Technician

Our client, a medical device subsidiary of a global pharmaceutical company, is looking for a:

Site Quality Source Technician

Overall responsibilities:
The Site Quality Source Technician is responsible for the execution of the Product Release
Certification and Monitoring program for products manufactured by the Strategic Collaborator (SC). He/she ensures that the SC has a clear understanding and the ability to execute against company's product release requirements.

Position duties and responsibilities:

  • Executes the Lot Release Certification and Monitoring Program for company products according to established procedures:
  • Training of SC personnel performing product release of company's sterile and non-sterile products as part of the Certification Program.
  • Perform certification, re-certification, and decertification of SC product release personnel.
  • Monitor SC's product release performance through the review of a sample of Device History Records (DHR) in accordance to approved sampling plans.
  • Develop work plans to meet certification and monitoring weekly requirements including any necessary adjustments based on production schedules, holidays, and sampling plan revisions.
  • Generate Nonconformance Reports (NCR) resulting from the product release monitoring process as per applicable approved procedures. Partnerships with the SC on the timely resolution of product release monitoring related NCRs and any other discrepancies found during the DHR monitoring process.
  • Track lot release certification and monitoring data in order to measure program effectiveness and to identify trends. Report data analysis, including any negative trend, to his/her direct supervisor.
  • Recommend process and procedural improvements as it relates to the product release certification and monitoring program.
  • Perform additional tasks on supervisor's request.

Job profile:
Education Requirements:

  • High school or equivalent

Experience:

  • 5 years of related experience is preferred

Interpersonal skills / characteristics (if applicable):

  • Quality-oriented mindset
  • Communication skills
  • Independency
  • Integrity
  • Able to communicate and writing skills in English (preferred)
  • Flexibility
  • Service minded

Minimum Language required

  • German: Very good for German speaking sites
  • English: Basics
  • Italian: Very good Business fluent for Mezzovico

12.06.2019
Employee, 100%

Contact

Randstad (Schweiz) AG
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