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Qualified Person
Eingestellt von Experis
Gesuchte Skills: Controller
Projektbeschreibung
The Qualified Person will be responsible for supporting the Quality Assurance audit function to ensure GMP compliance both within the company and at key suppliers; accompany and coordinate regulatory inspections from external bodies; review batch manufacturing records and the process of manufacture supporting the decision to release product in compliance with all license and GMP requirements; operate to a code of conduct defined by the joint professional bodies; represent QA on a range of development projects and advise on the adequacy of validation of facilities, equipment and new products/processes, including designing strategies to ensure adequate data is gathered; contribute to the development of policy within the QA organisation; actively participate in accident coordinate Product Corrective Action activities and liaise with the regulatory agencies as appropriate in these circumstances.
Qualification & Skill Requirements:
- Eligible for Qualified Person status on UK product licenses under Directive 2001/83/EC
- Degree in relevant science subject from a recognised University or equivalent
- Experience in a relevant field in the pharmaceutical industry
- Member of the relevant professional body eg RPSGB
- Experience of inspections from regulatory agencies eg FDA and MHRA
- Computer literate eg Word, Outlook, Excel, PowerPoint
- Excellent verbal and written communication skills
Please apply through this advert of alternatively call Stef Walters.
Projektdetails
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Einsatzort:
Amersham, Vereinigtes Königreich
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Projektbeginn:
asap
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Projektdauer:
3 months +
- Vertragsart:
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Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
Organisation/Management