Quality Assurance Auditor

View: 167

Update day: 25-04-2024

Location: Bern Bern BE

Category: Quality Assurance / Quality Control

Industry: Biotechnology Research Pharmaceutical Manufacturing

Position: Mid-Senior level

Job type: Full-time

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Job content

QUALITY ASSURANCE ARCHITECT

Location: Bern

Duration: 10 Months

Assist the Regulatory Compliance team with the following tasks, but not exclusively:

Authority- and customer inspections at the CSL Bern site
Preparation of GMP documents for regulatory submissions
Responses to questions from regulators
Coordination, performance and follow-up of paper based GMP inspections
Preparation of GMP-certificate renewal and tender relevant documentation based on request by Affiliates
Change Management: Ensuring timely implementation of Regulatory Compliance related actions
Supporting answers to Regulatory Compliance related questions from internal or external
Perform Ad-Hoc duties in specialized field
Participation in predetermined trainings
Compliant performance of activities after appropriate training

Requirements:

Education: University degree or university of applied sciences degree in natural sciences (e.g. Biology, Chemistry or Pharmacy)
Experience in Quality or manufacturing in a pharmaceutical GMP environment
Experienced in reading regulations
Demonstrated german and english skills (written and spoken)
Demonstrated communication skills
Demonstrated interest for technical processes
Experience with management of Audits

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