Proclinical Staffing

QA Specialist

Location
Basel, Switzerland
Salary
Negotiable
Posted
07 May 2021
Closes
21 May 2021
Ref
37415
Contact
Chloe Yeung
Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
A world leading pharmaceutical company is looking for QA Specialist to join their extraordinary team and help them make healthcare safer for everyone.

Job Responsibilities

  • Initiate, support and supervise qualifications of complex analytical equipment in close collaboration with the analytical laboratories.
  • Act as a trainer for relevant qualification topics.
  • First point of contact to Quality Compliance in all topics related to your field of work.
  • Actively participate in global teams, projects, networks and/or platforms. Fulfill all re-
  • lated tasks and responsibilities related to own discipline.
  • Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team member(s).
  • Interact with authorities / inspectors where appropriate. Act as SME regarding sys- tem qualification topics.
  • Interpret results, evaluate data, draw relevant conclusions and write reports.
  • Interact/collaborate with other teams/functions to facilitate transfer of knowledge. 1 4. Actively contribute to team goals.
  • Contribute to evaluation of new scientific technologies/equipment and prepare CAR
  • and URS if applicable.
  • Coach/lead team members: support objectives setting, participate in recruiting processes if applicable.
  • Strategic and scientific contribution to Networks, target achievements according to network charter and annual objectives

Skills and Requirements

  • Technical expert studies with PhD and 0-2 years relevant experience
  • Master of Science with 4 years of relevant experience
  • Bachelor of Science or equivalent technical education with 8 years relevant experience in industry or equivalent
  • Fluent in English (oral and written) Basic skills in local site-language (German), as
  • required for the position & Awareness of safety regulations and for safe
  • handling of chemicals and equipment. Appropriate number of years of experience in an analytical GMP environment.
  • Very good knowledge of qualification processes for laboratory systems in a GMP environment including software qualification (CSV) and related technical tools and software.
  • Scientific project management and leadership skills
  • Good knowledge on relevant regulatory guidelines and good understanding of regulatory expectations

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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