Quality Manager for CMOs (m/f/d) – Freelance

  • Position zu besetzen ab 1. Juni 2019
  • Permanent-ID OCR-FL-2019-1041
  • Branche Pharma
  • Beschäftigungsform Freelance/ Contracting
  • Standort Deutschland / 6x
  • Kategorien Beschäftigungsform, Branche, Freelance/Contracting, Pharma

Aufgaben

This position will be responsible to support Merck ESQ (External Supply Quality) to manage the Quality oversight activities for contract manufacturing operations (CMOs) to meet compliance and business requirements.

Specifically, the following activities will be in scope of the assignment: For 4 CMOs:

–      Finalize CMO Quality Audit follow up and verify CAPA status in response to internal audit findings incl. auditor approval

–      Drive audit CAPA resolution

–      Manage the Deviation, investigation and CAPA with CMO and Merck Local QA

–      Manage Change Control with CMO, Merck Local QA and all SME within Merck (CCP Action coordination, CC approval and closure)

–      Review Validation and Batch documentation with Local QA and relevant Subject Matter Expert within Merck

–      Follow up the Mitigation Plan defined for each CMO

–      Update the QTA with CMO and support Local QA to negotiate and finalize with CMO

Anforderungen

  • Assessment Report 3-5 yrs.
  • CMO Quality Audit> 5 yrs.
  • CMO Quality Risk Assessment> 5 yrs.
  • Complete Quality> 5 yrs.
  • Drive audit CAPA resolution> 5 yrs.
  • English and German : business fluent

Zusätzliche Informationen

Standort: Darmstadt

Projektbeginn: Juni 2019

Projektlaufzeit: bis 31.08.2019 mit Verlängerungsoption

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