Beschreibung
Quality Assurance Expert Analytics Drug Product Services (m/f/d)
Reference: -en
Start: asap
Duration: 6 MM++
Main tasks:
- Establish and maintain Quality Management System for Drug Product Services
- Ensure proper qualification of DPS staff and adherence to GMP for stability studies and reference standards
- Review and approve methods, qualification/validation/transfer protocols and reports as well as analytic related SOPs
- Act as fist contact concerning compliance issues for local and shared systems (e.g. LIMS) including approval of specifications in LIMS
- Make sure all relevant parties adhere to GMP regulations and quality agreements
- Verify compliant qualification of suppliers, material, equipment, instruments (incl. CSV) and validation of methods and processes
- Supervise and execute GMP compliance activities and act as last approver of major deviations for Analytics/Quality Control and OOS investigations
- Counsel different groups on projects and GMP aspects
Main qualifications
- Academic degree (Master or higher) in Chemistry, Biochemistry, Pharmaceutical Sciences or related field
- Significant working experience in Quality Assurance in pharmaceutical industries and cGMP controlled environment
- Good working knowledge in EU and US GMP regulations relevant for audit/inspections, qualification/validation, compliance systems
- Sound knowledge in testing of biological drug products
- Excellent communication and decision making skills
- Ability to work independently in a team environment
- Excellent knowledge of written and spoken English
Main advantages:
- Possibility to take up a permanent employment with our customer
- A very renowned company
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays:
My contact person:
Marc-Sebastian Heftrich
Referencenumber:
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