CH - Quality Engineers, Validation Consultant - Normal

Highly Competitive
  1. Permanent
  2. Validation
  3. Switzerland
Solothurn
Posting date: 17 Jun 2019
VA.CM.23723_1560783499

An internationally renowned pharmaceutical company is currently advertising a Quality Engineer, Validation Consultant to their office in Switzerland. This top 10 pharma company works across multiple sectors, including medical devices, pharmaceutical research, and consumer health. The vacancy offers an exciting opportunity to work with a company with over 100,000 professionals around the globe.

Job Responsibilities:

  • Effectively and efficiently developing, transferring, and maintaining products/processes throughout the product lifecycle.
  • Improving and maintaining products/processes that are aligned with the overall Quality and Business vision.
  • Preventing unanticipated failure modes and improve capability of processes.
  • Creating protocols and reports for IQ, OQ, PQ, Test Method Validation (TMV), or Software Validation.
  • Collaborating with other departments (Manufacturing, Engineering, Inspection, logistic) to ensure the proper execution of the validation and the tests.
  • Leading small projects in a timely manner.

Skills and Requirements:

  • A minimum of a Bachelor's Degree, preferably in Engineering or related technical field.
  • A minimum of 5 years related experience in validation.
  • Experience working in both an FDA and European regulatory environment is preferred.
  • Relevant experience working in manufacturing/operations.
  • An In-depth knowledge of product/process Risk Management (FDA and ISO standards).
  • Experience with a proven track record of implementing appropriate risk mitigation.
  • Technical training and experience using statistics, Lean and Six Sigma Methodologies is required including Measurment System Analysis.
  • Good technical understanding of manufacturing equipment and processes.
  • Understanding of the NPI (New Product Introduction) process and Process Validation expertise.
  • A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
  • Sound product validation experience.
  • Experience in reading product drawings.
  • Fluency in German.
  • Demonstrated project management skills.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

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 contact Caleb Mensah at +44 203 854 1080 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.

#LI-CM3

#Compliance/Quality

close