HPZ Quality Manager (m/w/d) Clinical Research Associate (m/w/d) GCP Auditor (m/w/d)

95000,00 Euro pro Jahr

Оccupation: Quality engineer

For our long-term customers in the pharmaceutical industry, we offer the Chiffre-Nr. 2140 from now on the entry via employee transfer with takeover possibility a place as

Projektmanager (m/w/d)

Job ID: 2140

You can look forward to this:

• Entry to one of the world's TOP companies
• A demanding and responsible activity
• The same monthly gross amount as in fixed employment from the 1st working day (approximately € 95,000 p.a. depending on the relevant professional experience)
• Personal care by fixed contact persons
• Hybrid working model, which can also be covered from the Home Office/remote by day after consultation
• A safe and long-term job with good takeover opportunities
• A fair and trusting relationship
• This position is a hybrid working model which can be covered from the Home Office/remote on 1 to 2 days per week after consultation or as required. The incorporation takes place on site

Job contents:

• Organisation/Support for the preparation, implementation and follow-up of inspections, internal and external audits and assessments including timely creation of action plans and their follow-up in close cooperation with Quality Medicine Germany
• Support and responsibility for the creation and management of Controlled Documents and templates for HPZ processes and verification of relevance for HPZ functions and matching with SOP distributor lists and incorporation lists (the HPZ-specific curriculum)
• Self-fulfilment of quality controls, e.g. check of relevant audit procedures and documentation (source data, CRFs, ICs, internal process descriptions, etc.) and initiation of process improvement measures and CAPAs
• Supporting the HPZ team through advice and assistance on quality, processes, SOPs, improvement activities and data protection

Requirements:

• Completed study with multi-year relevant experience or equivalent qualification with relevant training and long-term professional experience. In principle, various disciplines are conceivable here, e.g. a natural science study (e.g. biology, pharmacy, chemistry), pharmaceutical sciences/clinic research, health sciences/Public Health, quality management/Regulatory Affairs. Or a Master's degree course Clinical Trial Management, GCP or Quality Management in Healthcare
• Long-term experience in clinical trials of Phase 1 (e.g. as Study Nurse, Clinical Research Associate, GCP Auditor)
• Very good understanding of clinical research, quality management and regulatory requirements
• Very good knowledge of relevant international and national regulations, e.g. GCP, AMG, MPG, GCP-V, relevant guidelines (ICH, FDA, EMA)
• Experience in quality management and training of employees
• German and English fluent in word and writing
• Ability to identify problems independently and at an early stage as well as to solve them in a highly independent and targeted manner
• team capacity as well as effective, efficient and, in particular, need-oriented communication and cooperation with cultural empathy

We also look for:

• Pharmaceutical Analysis (m/w/d), Bioanalytical Chemistry (m/w/d), Biopharmaceutical Science (m/w/d), Clinical Trial Management (m/w/d), Pharmaceutical Biotechnology (m/w/d), Pharmazeutische Biotechnologie (m/w/d)

Mr. Achim Zintgraf will be able to contact you by phone at the telephone for further information on the job. [for phone number see the original ad] available. Please send your application by e-mail (Annex/Appendices can only be accepted in the PDF file format) to [for e-mail see the original ad]

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Joblocations:

88400 Biberach an der Riß, BADEN_WUERTTEMBERG, GERMANY

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