QA Manager for product launch.

Job ID: 10874

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Project Consulting
Ihre Aufgaben
  • QA Aufgaben:

    • Review, investigation and approval of all Quality events including (Deviation, OOS, CAPA, Change Control, etc.)

    • Within the framework of the project, the preparation process was tested and investigated for deviations during the process or apparent in the analysis certificate (if product is out of specification)

    • Most of the time deviations were able to correct with immediate actions or corrections or there was need of corrective or preventive actions (CAPA). In this case the correctiive of prevetive actions were carried out and observed for effectiveness

    • Review and approve related documents (SOPs, Batch records, etc.)

    • The documents of the preparation process have been reviewed and approved if necessary to ensure the effectiveness of the preparation process and the quality of the product

    • Conduct all other relevant day-to-day quality, GMP compliance and QC activities and decisions

    • Daily check of the instrumental devices was monitored as well as the results of the analyses of the starting materials and intermediate products. 
    • Ensures operational effectiveness of the site QA/QC department

    • Maintain Site Inspection Readiness
    • Participation at audit arragements, als the project has been auditorized

    • Promote Compliance Audit findings/remediation
    • Insure that product(s) are manufactured and released in compliance with regulatory requirements

    • Work directly with the clients site and QA management with regards to day-to-day logistics