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Senior QA Expert (Inspection Management) (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Projektbeschreibung
REFERENZNUMMER:
344489/11
IHRE AUFGABEN:
-Ensure inspection readiness with cGMP legal and regulatory requirements
-Maintain the annual inspection/audit schedule
-Lead and coordinate the preparation and execution of health authority inspections, customer audits and internal inspections
-Coordinate the timely preparation of written responses to inspection/audit reports and ensure that adequate corrective and preventive actions are defined and implemented on time
-Annually compile the Site Quality Plan (SQP) and regularly monitor progress of each project against the associated timelines
-Ensure that self inspections are executed according to a predefined program and ensure follow-up of corrective and preventive actions
-Manage the non-batch related contract manufacturing quality aspects (reverse contractors)
-Ensure that a valid quality agreement is in place in line with the requirements of the global template
-Ensure that all aspects of the handling, manufacturing and distribution of supplied products are in compliance
-Write, review and approve SOPs/forms associated with above duties
IHRE QUALIFIKATIONEN:
-(Technical) university/academy degree in chemistry, pharmacy or equivalent
-Professional experience in quality control/quality assurance and in the manufacturing of pharmaceutical drug products
-Profound knowledge in cGMPs
-Proven track record with FDA, EMEA and other health authorities
-Strong understanding of risk assessment and risk management fundamentals/tools
-Technical understanding of pharmaceutical/biological processes
-Extensive auditing experience
-Fluency in German (spoken/written)
-Very good English skills (spoken/written)
WEITERE QUALIFIKATIONEN:
Quality manager
344489/11
IHRE AUFGABEN:
-Ensure inspection readiness with cGMP legal and regulatory requirements
-Maintain the annual inspection/audit schedule
-Lead and coordinate the preparation and execution of health authority inspections, customer audits and internal inspections
-Coordinate the timely preparation of written responses to inspection/audit reports and ensure that adequate corrective and preventive actions are defined and implemented on time
-Annually compile the Site Quality Plan (SQP) and regularly monitor progress of each project against the associated timelines
-Ensure that self inspections are executed according to a predefined program and ensure follow-up of corrective and preventive actions
-Manage the non-batch related contract manufacturing quality aspects (reverse contractors)
-Ensure that a valid quality agreement is in place in line with the requirements of the global template
-Ensure that all aspects of the handling, manufacturing and distribution of supplied products are in compliance
-Write, review and approve SOPs/forms associated with above duties
IHRE QUALIFIKATIONEN:
-(Technical) university/academy degree in chemistry, pharmacy or equivalent
-Professional experience in quality control/quality assurance and in the manufacturing of pharmaceutical drug products
-Profound knowledge in cGMPs
-Proven track record with FDA, EMEA and other health authorities
-Strong understanding of risk assessment and risk management fundamentals/tools
-Technical understanding of pharmaceutical/biological processes
-Extensive auditing experience
-Fluency in German (spoken/written)
-Very good English skills (spoken/written)
WEITERE QUALIFIKATIONEN:
Quality manager
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Sonstiges