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Freelance Consultant GMP Compliance (m/w/d) (DE)
[12983]
compliance, GMP, QMS
Zu besetzendes Projekt: Freelance Consultant GMP Compliance (m/w/d) Branche: Pharma Fähigkeiten: compliance,GMP,QMS Projektstart: 15.09.2023 Projektdauer: 31.01.2023 Auftragsvolumen: 800 Stunde(n) Einsatzort: Bern, Schweiz Aufgaben: ·Create, distribute and track regulatory/compliance gap Analysis observations at the sites. Collaboration with Quality compliance teams is essential to ensure Gap Analysis observations and content is fostering increased compliance ·Responsible for the Regulatory intelligence process and tool (Redica) as assigned. The role ensures that information is used to its maximum potential: support to site inspection, gap assessment, trending of major Inspection observations… ·Responsible to manage global Quality Risk Management by coordinating frequent review of the site risk profile in regards to Quality Risks (CORP-28) as assigned. Analyse the data to define top quality and compliance risks that is communicated to management. ·Responsible that metrics are set and maintained globally to measure quality compliance and provide KPIs to BU Quality councils and Global Quality Council Qualifikationen: ·3++ years experience in the pharmaceutical industry ·Studies in pharmacy, chemistry, biotechnology or similar ·Experience with GMP compliance and risk management
Fähigkeiten: compliance,GMP,QMS
- Create, distribute and track regulatory/compliance gap Analysis observations at the sites. Collaboration with Quality compliance teams is essential to ensure Gap Analysis observations and content is fostering increased compliance
- Responsible for the Regulatory intelligence process and tool (Redica) as assigned. The role ensures that information is used to its maximum potential: support to site inspection, gap assessment, trending of major Inspection observations…
- Responsible to manage global Quality Risk Management by coordinating frequent review of the site risk profile in regards to Quality Risks (CORP-28) as assigned. Analyse the data to define top quality and compliance risks that is communicated to management.
- Responsible that metrics are set and maintained globally to measure quality compliance and provide KPIs to BU Quality councils and Global Quality Council
- 3++ years experience in the pharmaceutical industry
- Studies in pharmacy, chemistry, biotechnology or similar
- Experience with GMP compliance and risk management
Sandra Hermann