Quality Assurance Audit

View: 156

Update day: 25-04-2024

Location: Bern Bern BE

Category: Quality Assurance / Quality Control

Industry: Pharmaceutical Manufacturing

Position: Entry 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

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.

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