Specialist (m/w/d) Change Control New Assets / GDP at Merz Therapeutics
Frankfurt am Main, Hessen, Germany -
Full Time


Start Date

Immediate

Expiry Date

27 May, 25

Salary

0.0

Posted On

27 Feb, 25

Experience

3 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Participation, Maintenance

Industry

Pharmaceuticals

Description

YOUR CONTRIBUTION

Join our global quality operations team and grow with exciting challenges. With your passion and expertise and together with our international colleagues, you will contribute to achieving our company goals. As a Specialist in Quality, your responsibilities will include the following tasks:

  • Establishment, development, and maintenance of the Change Control system for New Assets
  • Processing Change Control requests in the JIRA ECC module
  • Monitoring the Change Control process in the JIRA ECC module, considering cGMP/ISO requirements. Recording KPIs and actively tracking major and release-relevant changes
  • Development and improvement of the Change Control process, implementation of improvements and open actions, and their backlog tracking in the JIRA ECC module
  • Participation in the creation/update of relevant SOPs
  • Training employees on the change control process
Responsibilities
  • Establishment, development, and maintenance of the Change Control system for New Assets
  • Processing Change Control requests in the JIRA ECC module
  • Monitoring the Change Control process in the JIRA ECC module, considering cGMP/ISO requirements. Recording KPIs and actively tracking major and release-relevant changes
  • Development and improvement of the Change Control process, implementation of improvements and open actions, and their backlog tracking in the JIRA ECC module
  • Participation in the creation/update of relevant SOPs
  • Training employees on the change control proces
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