Projectmanager Data Integrity (m/w/d) – Freelance – on hold

  • Position zu besetzen ab 10. Januar 2022
  • Permanent-ID OCR-FL-1603
  • Branche Pharma
  • Beschäftigungsform Freelance/ Contracting
  • Standort Deutschland / 6x
  • Kategorien Beschäftigungsform, Branche, Freelance/Contracting, Pharma

Task:
Our client requires interim support as Project Manager for Manager Global Change Control Improvement:
Our client implemented Global Change Control Process together with eQMS „Ma-nagement of Change“ module in March 2021. The coordination role was assigned to the Quality Department. Based on the hypercare phase of current process implemen-tation it turned out that improvements are required.
The scope of this project is to review the current implemented process of the global change control process, to lean the workstreams, identify possibilities to improve the process resp. to make it more efficient, align it within the current IT system and rede-fine communication streams and responsibilities, if needed.
Goals of the Project is to provide process overview of the new process, stated in SOPs and OPs and a proposal list of possible improvements with the IT system, including fea-sibility check.
For the project it is required to review all applicable SOPs and OPs, reassess the current IT System (MoC Module in EQMS), facilitate workshops, conduct meetings, track cur-rent state of the project, provide process maps and written procedures.

Skills:
• Completed scientific university degree or corresponding scientific/ phar-maceutical training with further qualification
• Min. 10 years of experience in the quality area of a pharmaceutical company particularly knowledge about Change Mangement in GMP environment
• knowledge of the requirements for data integrity are required
• Experience with digital eQMS Change modules (e.g. MoC module from Master-Control) is desirable
• Qualification and practical experience in project management
• Business fluency in English; German desired
• Willingness to travel abroad

Additional Information:
Location: GR Frankfurt
Project start: December 2021/January 2022
Duration: 6 months
Availability: 40h/week
On-site: 60%
Remote: 40%

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