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Audit and Inspection Preparation Manager (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Support
Projektbeschreibung
REFERENZNUMMER:
316418/11
IHRE AUFGABEN:
-Prepare and carry out FDA inspection and possible audits
-Write reports as per assigned timelines
-Identify/handle non-conformances pro-actively
-Provide GMP and ideally GCP oversight of the inspection
-Supervision of specific risked-based inspections and audit plans, review resulting CAPAs, request additional audits as required (e.g. potential data integrity issues)
-Ensure QA CRO oversight
-Support QA GOP review
IHRE QUALIFIKATIONEN:
-Degree in Life Sciences, pharmaceutical or other related science or equivalent experience
-FDA inspection and auditing experience, knowledge of GMP and ideally GCP/ICH guidelines
-Strong background in research & development, manufacturing and quality control allowing for understanding all departments needs and constraints
-Extensive knowledge of quality management systems for compliance with ISO 13485, ISO 9001 and 21CFR820, in the medical device industry from establishment to implementation, maintenance and continuous improvement
-Work experience in Quality Assurance and in a Clinical Development department
-Experience in managing authority inspections
-Good communication and negotiation skills
-Fluency in English, in both written and verbal form
WEITERE QUALIFIKATIONEN:
Auditor
316418/11
IHRE AUFGABEN:
-Prepare and carry out FDA inspection and possible audits
-Write reports as per assigned timelines
-Identify/handle non-conformances pro-actively
-Provide GMP and ideally GCP oversight of the inspection
-Supervision of specific risked-based inspections and audit plans, review resulting CAPAs, request additional audits as required (e.g. potential data integrity issues)
-Ensure QA CRO oversight
-Support QA GOP review
IHRE QUALIFIKATIONEN:
-Degree in Life Sciences, pharmaceutical or other related science or equivalent experience
-FDA inspection and auditing experience, knowledge of GMP and ideally GCP/ICH guidelines
-Strong background in research & development, manufacturing and quality control allowing for understanding all departments needs and constraints
-Extensive knowledge of quality management systems for compliance with ISO 13485, ISO 9001 and 21CFR820, in the medical device industry from establishment to implementation, maintenance and continuous improvement
-Work experience in Quality Assurance and in a Clinical Development department
-Experience in managing authority inspections
-Good communication and negotiation skills
-Fluency in English, in both written and verbal form
WEITERE QUALIFIKATIONEN:
Auditor
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Sonstiges