Arbeitsort: Deutschland, HESSEN
Vertragsart: Vollzeit
Benötigte Ausbildung: keine Spezifikation
Angebotener Lohn: keine Angaben
Anzahl der Arbeitsplätze: 1
Berufsfeld
Geschäftsleiter und Geschäftsbereichsleiter in großen Unternehmen
Produktions- und operationsleiter
Anderweitig nicht genannt
Aufgabenbereich:
Do you just love being positively surprised? Then you should take a closer look at this challenging opportunity! Since we are achieving sustained expansion worldwide, it means that you
- and this shouldn
- t surprise you
- can determine your own career path with us. It goes without saying that no matter where you go within the company, we offer you an exciting environment. What else awaits you? Be surprised! Strengthen our team as a Senior Clinical QA Auditor (m/f) You are responsible for Clinical Quality Assurance audits in support of clinical research projects across multiple therapeutic areas. This role will reports to the Head of Research QA (Functional Manager, based in Cambridge/UK). Your Line Manager will be the Executive Director of Quality (Mundipharma GmbH/Limburg). Main tasks:
- Assist the Head of Research QA with audit planning and maintenance of Clinical Quality Assurance (CQA) Audit Schedule. Mentor other auditor within CQA.
- Conduct investigator site audits to assess the integrity of the study data and to determine whether studies are being conducted in compliance with the appropriate GCP guidelines and SOPs.
- Perform evaluations and audits of any vendors and internal process audits.
- Support our Clinical Studies with good sound compliance advice as a member of the CST.
- Lead audit teams where the scope of an audit requires multiple auditor input.
- Support the team to ensure that suitable SOPs and documents are compliance with ICH GCP.
- Generate effective Audit Reports in accordance with Research QA procedures.
- Assist the company and any independent associated companies with preparation for statutory regulatory GCP inspection.
- Keep up-to-date with the latest advances in clinical research regulation and advise our clients for any GCP issues.
- Maintain up to date knowledge of external guidelines and industry standards and provide CQA support to IACs. Requirements:
- Science degree or equivalent with relevant work experience and a track record in the field of CQA.
- Significant experience of auditing clinical studies including multinational ones and of ICH GCP.
- Excellent knowledge of clinical development process will be required.
- Depth knowledge of auditing techniques and a detailed understanding of the drug development process.
- Proven leadership and excellent communication skills.
- Ability to work independently and to mentor more junior staff. Assist with CQA staff training, when requested. If you have any queries or would like to apply, then please contract Christa Frost-Rohrmoser
- Christa.Frost-Rohrmoser@mundipharma.de - Geforderte Anlagen: significant application documents; Kenntnisse und Fertigkeiten: Qualitätsaudit; Qualitätsmanagement; Qualitätsprüfung, Qualitätssicherung
Arbeitszeit:
- Ohne Arbeitszeitbestimmung
Anforderungen
source: https://www.ec.europa.eu/eures
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